Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## Resource Profile: Manufactured Drug Product

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: FinishedProduct
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.29

The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component.

Usages:

- Use this Profile: CMC eCTD 32P10 Document
- Refer to this Profile: eCTD Product Description and Composition

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ManufacturedItemDefinition | C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..1 | Identifier | Unique identifier
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name | S Σ | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
Slices for property | S Σ | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept
property:OvrRelsProf | S Σ | 1..1 | BackboneElement | Product Overall Release Profile
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Profile
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech | S Σ | 0..1 | BackboneElement | Product Overall Release Mechanism
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Mechanism
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd | S Σ | 0..1 | BackboneElement | Product Coating Indicator
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Indicator
value[x] | S Σ | 1..1 | boolean | A value for the characteristic
property:LayCnt | S Σ | 0..1 | BackboneElement | Product Tablet Layer Count
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Layer Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:BeaTypCnt | S Σ | 0..1 | BackboneElement | Tablet Bead Type Count
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Bead Type Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:CapClass | S Σ | 0..1 | BackboneElement | Capsule Shell Part Classification Category
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Classification Category
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt | S Σ | 0..1 | BackboneElement | Product Capsule Constituent Count
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Constituent Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:Schematic | S Σ | 1..* | BackboneElement | Product Schematic
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Schematic
value[x] | S Σ | 1..1 | GraphicAttachment, PDFAttachment | A value for the characteristic
property:WgtTyp | S Σ | 1..1 | BackboneElement | Product Weight Type
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Weight Type
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum | S Σ | 1..1 | BackboneElement | Product Total Weight Numeric Numerator
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (extensible)
comparator | ?!S Σ | 0..1 | code | Product Total Weight Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:TotWgtDen | S Σ | 0..1 | BackboneElement | Product Total Weight Numeric Denominator
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator
value[x] | S Σ | 1..1 | SimpleQuantity | A value for the characteristic Binding: Units Of Measure (extensible)
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
property:TotWgtTxt | S Σ | 0..1 | BackboneElement | Product Total Weight Textual
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Total Weight Textual
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
property:QualStd | S Σ | 1..* | BackboneElement | Product Quality Standard
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Quality Standard
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile | S Σ | 1..1 | BackboneElement | Sterile Product Indicator
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Sterile Product Indicator
value[x] | S Σ | 1..1 | boolean | A value for the characteristic
component | S Σ C | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup Constraints: cmc-amount-ratio-or-quantity
Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | ?!S Σ | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
type | S Σ | 1..1 | CodeableConcept | Product Part Type
coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Product Part Type Terminology (required)
function | S Σ | 0..* | CodeableConceptTextOnly | Product Part Function Description
Slices for amount | S Σ | 1..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S Σ | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S Σ | 1..1 | decimal | Product Part Total Weight Numeric
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Total Weight Numeric UOM
code | Σ C | 0..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S Σ | 1..1 | decimal | Product Part Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Content Percent UOM
code | Σ C | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S Σ C | 1..* | BackboneElement | Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:textualStrength | S | 0..1 | (Complex) | Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/StructureDefinition/originalText"
value[x] |  | 1..1 | string | Textual Strength
Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | ?!S Σ | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
Slices for amount | S Σ | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S Σ | 0..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value | S Σ | 1..1 | decimal | Product Part Ingredient Amount Numeric
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Ingredient Amount Numeric UOM
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value | S Σ | 1..1 | decimal | Product Part Ingredient Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Ingredient Content Percent UOM
code | Σ C | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location
coding | S Σ | 1..1 | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text | S Σ | 0..1 | string | Plain text representation of the concept
Slices for function | S Σ | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category | S Σ | 1..1 | CodeableConcept | The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function | S Σ | 0..1 | CodeableConcept | Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient | S Σ | 1..1 | LiteralCodeableReference(Drug Product Component) {b} | The ingredient that is the constituent of the given component
Slices for property | S Σ | 2..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept
property:PPiD | S Σ | 1..1 | BackboneElement | Product Part Identifier
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:PPiDref | S Σ | 0..1 | BackboneElement | Product Part Identifier Reference
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:RelsProf | S Σ | 1..1 | BackboneElement | Product Part Release Profile
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Profile
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech | S Σ | 0..1 | BackboneElement | Product Part Release Mechanism
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Mechanism
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose | S Σ | 0..* | BackboneElement | Coating Product Part Purpose
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Product Part Purpose
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color | S Σ | 0..1 | BackboneElement | Product Part Color Description
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Color Description
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:AddInfo | S Σ | 0..1 | BackboneElement | Product Part Additional Information
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
ManufacturedItemDefinition.status | required | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology` From this IG
ManufacturedItemDefinition.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.property:OvrRelsMech.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.property:CoatInd.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:CapClass.value[x] | required | PqcmcCapsuleClassificationCategory `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category` From this IG
ManufacturedItemDefinition.property:CapConCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.value[x] | required | PqcmcStrengthTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology` From this IG
ManufacturedItemDefinition.property:TotWgtNum.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtTxt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:QualStd.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:QualStd.value[x] | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
ManufacturedItemDefinition.property:Sterile.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.type.coding | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:weight.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.amount:percent.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:weight.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.location.coding | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` From this IG
ManufacturedItemDefinition.component.constituent.function:Category | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
ManufacturedItemDefinition.component.constituent.function:Function | required | PqcmcExcipientFunctionTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology` From this IG
ManufacturedItemDefinition.component.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.component.property:RelsMech.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x] | required | PqcmcCoatingPurpose `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose` From this IG
ManufacturedItemDefinition.component.property:Color.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-amount-ratio-or-quantity | error | ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent | The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 ) |
cmc-arbitrary-unit-text-required | error | ManufacturedItemDefinition | BR - Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists()) |
cmc-capsule-classification-required | error | ManufacturedItemDefinition | when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists()) |
cmc-capsule-count-required | error | ManufacturedItemDefinition | Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists()) |
cmc-coating-indication-required | error | ManufacturedItemDefinition | Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists()) |
cmc-component-id-ref | error | ManufacturedItemDefinition | If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() ) |
cmc-ingredient-functions | error | ManufacturedItemDefinition.component.constituent | If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2 |
cmc-tablet-bead-count-required | error | ManufacturedItemDefinition | Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists()) |
cmc-tablet-layer-count-required | error | ManufacturedItemDefinition | Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists()) |
dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | ManufacturedItemDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from ManufacturedItemDefinition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ManufacturedItemDefinition | C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref
identifier | S | 0..1 | Identifier | Unique identifier
status | S | 1..1 | code | draft | active | retired | unknown
name | S | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm |  | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
Slices for property | S | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
type | S | 1..1 | CodeableConcept | A code expressing the type of characteristic
text | S | 1..1 | string | Plain text representation of the concept
property:OvrRelsProf | S | 1..1 | BackboneElement | Product Overall Release Profile
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Profile
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech | S | 0..1 | BackboneElement | Product Overall Release Mechanism
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Mechanism
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd | S | 0..1 | BackboneElement | Product Coating Indicator
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Indicator
value[x] | S | 1..1 | boolean | A value for the characteristic
property:LayCnt | S | 0..1 | BackboneElement | Product Tablet Layer Count
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Layer Count
value[x] | S | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S | 1..1 | decimal | Numerical value (with implicit precision)
property:BeaTypCnt | S | 0..1 | BackboneElement | Tablet Bead Type Count
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Bead Type Count
value[x] | S | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S | 1..1 | decimal | Numerical value (with implicit precision)
property:CapClass | S | 0..1 | BackboneElement | Capsule Shell Part Classification Category
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Classification Category
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt | S | 0..1 | BackboneElement | Product Capsule Constituent Count
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Constituent Count
value[x] | S | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S | 1..1 | decimal | Numerical value (with implicit precision)
property:Schematic | S | 1..* | BackboneElement | Product Schematic
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Schematic
value[x] | S | 1..1 | GraphicAttachment, PDFAttachment | A value for the characteristic
property:WgtTyp | S | 1..1 | BackboneElement | Product Weight Type
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Weight Type
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum | S | 1..1 | BackboneElement | Product Total Weight Numeric Numerator
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator
value[x] | S | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (extensible)
comparator | S | 0..1 | code | Product Total Weight Operator
property:TotWgtDen | S | 0..1 | BackboneElement | Product Total Weight Numeric Denominator
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator
value[x] | S | 1..1 | SimpleQuantity | A value for the characteristic Binding: Units Of Measure (extensible)
value | S | 1..1 | decimal | Numerical value (with implicit precision)
property:TotWgtTxt | S | 0..1 | BackboneElement | Product Total Weight Textual
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Total Weight Textual
value[x] | S | 1..1 | markdown | A value for the characteristic
property:QualStd | S | 1..* | BackboneElement | Product Quality Standard
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Quality Standard
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile | S | 1..1 | BackboneElement | Sterile Product Indicator
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Sterile Product Indicator
value[x] | S | 1..1 | boolean | A value for the characteristic
component | S C | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup Constraints: cmc-amount-ratio-or-quantity
Slices for modifierExtension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | S | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
type | S | 1..1 | CodeableConcept | Product Part Type
coding |  | 0..* | Coding | Code defined by a terminology system Binding: Product Part Type Terminology (required)
function | S | 0..* | CodeableConceptTextOnly | Product Part Function Description
Slices for amount | S | 1..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Product Part Total Weight Numeric
unit | S | 1..1 | string | Product Part Total Weight Numeric UOM
code |  | 0..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Product Part Content Percent
unit | S | 1..1 | string | Product Part Content Percent UOM
code |  | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S C | 1..* | BackboneElement | Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:textualStrength | S | 0..1 | (Complex) | Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
value[x] |  | 1..1 | string | Textual Strength
Slices for modifierExtension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | S | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
Slices for amount | S | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S | 0..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Product Part Ingredient Amount Numeric
unit | S | 1..1 | string | Product Part Ingredient Amount Numeric UOM
code | S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S | 1..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Product Part Ingredient Content Percent
unit | S | 1..1 | string | Product Part Ingredient Content Percent UOM
code |  | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S | 0..* | CodeableConcept | Product Part Ingredient Physical Location
coding | S | 1..1 | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text | S | 0..1 | string | Plain text representation of the concept
Slices for function | S | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category | S | 1..1 | CodeableConcept | The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function | S | 0..1 | CodeableConcept | Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient | S | 1..1 | LiteralCodeableReference(Drug Product Component) {b} | The ingredient that is the constituent of the given component
Slices for property | S | 2..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
type | S | 1..1 | CodeableConcept | A code expressing the type of characteristic
text | S | 1..1 | string | Plain text representation of the concept
property:PPiD | S | 1..1 | BackboneElement | Product Part Identifier
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier
value[x] | S | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:PPiDref | S | 0..1 | BackboneElement | Product Part Identifier Reference
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x] | S | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:RelsProf | S | 1..1 | BackboneElement | Product Part Release Profile
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Profile
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech | S | 0..1 | BackboneElement | Product Part Release Mechanism
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Mechanism
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose | S | 0..* | BackboneElement | Coating Product Part Purpose
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Product Part Purpose
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color | S | 0..1 | BackboneElement | Product Part Color Description
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Color Description
value[x] | S | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:AddInfo | S | 0..1 | BackboneElement | Product Part Additional Information
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x] | S | 1..1 | markdown | A value for the characteristic
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology` From this IG
ManufacturedItemDefinition.property:OvrRelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.property:CapClass.value[x] | required | PqcmcCapsuleClassificationCategory `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category` From this IG
ManufacturedItemDefinition.property:WgtTyp.value[x] | required | PqcmcStrengthTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology` From this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:QualStd.value[x] | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
ManufacturedItemDefinition.component.type.coding | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.location.coding | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` From this IG
ManufacturedItemDefinition.component.constituent.function:Category | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
ManufacturedItemDefinition.component.constituent.function:Function | required | PqcmcExcipientFunctionTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology` From this IG
ManufacturedItemDefinition.component.property:RelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.component.property:RelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.component.property:CoatPurpose.value[x] | required | PqcmcCoatingPurpose `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-amount-ratio-or-quantity | error | ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent | The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 ) |
cmc-arbitrary-unit-text-required | error | ManufacturedItemDefinition | BR - Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists()) |
cmc-capsule-classification-required | error | ManufacturedItemDefinition | when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists()) |
cmc-capsule-count-required | error | ManufacturedItemDefinition | Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists()) |
cmc-coating-indication-required | error | ManufacturedItemDefinition | Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists()) |
cmc-component-id-ref | error | ManufacturedItemDefinition | If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() ) |
cmc-ingredient-functions | error | ManufacturedItemDefinition.component.constituent | If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2 |
cmc-tablet-bead-count-required | error | ManufacturedItemDefinition | Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists()) |
cmc-tablet-layer-count-required | error | ManufacturedItemDefinition | Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists()) |

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ManufacturedItemDefinition | C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..1 | Identifier | Unique identifier
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name | S Σ | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
unitOfPresentation | Σ | 0..1 | CodeableConcept | The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of the item, one of several possible
marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient | Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property | S Σ | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept
value[x] | Σ | 0..1 |  | A value for the characteristic
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueMarkdown |  |  | markdown |
valueAttachment |  |  | Attachment |
valueReference |  |  | Reference(Binary) |
property:OvrRelsProf | S Σ | 1..1 | BackboneElement | Product Overall Release Profile
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Profile
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech | S Σ | 0..1 | BackboneElement | Product Overall Release Mechanism
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Mechanism
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd | S Σ | 0..1 | BackboneElement | Product Coating Indicator
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Indicator
value[x] | S Σ | 1..1 | boolean | A value for the characteristic
property:LayCnt | S Σ | 0..1 | BackboneElement | Product Tablet Layer Count
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Layer Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:BeaTypCnt | S Σ | 0..1 | BackboneElement | Tablet Bead Type Count
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Bead Type Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:CapClass | S Σ | 0..1 | BackboneElement | Capsule Shell Part Classification Category
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Classification Category
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt | S Σ | 0..1 | BackboneElement | Product Capsule Constituent Count
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Constituent Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:Schematic | S Σ | 1..* | BackboneElement | Product Schematic
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Schematic
value[x] | S Σ | 1..1 | GraphicAttachment, PDFAttachment | A value for the characteristic
property:WgtTyp | S Σ | 1..1 | BackboneElement | Product Weight Type
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Weight Type
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum | S Σ | 1..1 | BackboneElement | Product Total Weight Numeric Numerator
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (extensible)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | Σ | 0..1 | decimal | Numerical value (with implicit precision)
comparator | ?!S Σ | 0..1 | code | Product Total Weight Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:TotWgtDen | S Σ | 0..1 | BackboneElement | Product Total Weight Numeric Denominator
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator
value[x] | S Σ | 1..1 | SimpleQuantity | A value for the characteristic Binding: Units Of Measure (extensible)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:TotWgtTxt | S Σ | 0..1 | BackboneElement | Product Total Weight Textual
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Total Weight Textual
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
property:QualStd | S Σ | 1..* | BackboneElement | Product Quality Standard
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Quality Standard
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile | S Σ | 1..1 | BackboneElement | Sterile Product Indicator
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Sterile Product Indicator
value[x] | S Σ | 1..1 | boolean | A value for the characteristic
component | S Σ C | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup Constraints: cmc-amount-ratio-or-quantity
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | ?!S Σ | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
type | S Σ | 1..1 | CodeableConcept | Product Part Type
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Product Part Type Terminology (required)
text | Σ | 0..1 | string | Plain text representation of the concept
function | S Σ | 0..* | CodeableConceptTextOnly | Product Part Function Description
Slices for amount | S Σ | 1..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S Σ | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Product Part Total Weight Numeric
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Total Weight Numeric UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Product Part Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Content Percent UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S Σ C | 1..* | BackboneElement | Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:textualStrength | S | 0..1 | (Complex) | Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/StructureDefinition/originalText"
value[x] |  | 1..1 | string | Textual Strength
Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | ?!S Σ | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
Slices for amount | S Σ | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S Σ | 0..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Product Part Ingredient Amount Numeric
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Ingredient Amount Numeric UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Product Part Ingredient Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Ingredient Content Percent UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | S Σ | 1..1 | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text | S Σ | 0..1 | string | Plain text representation of the concept
Slices for function | S Σ | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category | S Σ | 1..1 | CodeableConcept | The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function | S Σ | 0..1 | CodeableConcept | Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient | S Σ | 1..1 | LiteralCodeableReference(Drug Product Component) {b} | The ingredient that is the constituent of the given component
Slices for property | S Σ | 2..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept
value[x] | Σ | 0..1 |  | A value for the characteristic
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueMarkdown |  |  | markdown |
valueAttachment |  |  | Attachment |
valueReference |  |  | Reference(Binary) |
property:PPiD | S Σ | 1..1 | BackboneElement | Product Part Identifier
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:PPiDref | S Σ | 0..1 | BackboneElement | Product Part Identifier Reference
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:RelsProf | S Σ | 1..1 | BackboneElement | Product Part Release Profile
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Profile
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech | S Σ | 0..1 | BackboneElement | Product Part Release Mechanism
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Mechanism
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose | S Σ | 0..* | BackboneElement | Coating Product Part Purpose
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Product Part Purpose
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color | S Σ | 0..1 | BackboneElement | Product Part Color Description
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Color Description
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:AddInfo | S Σ | 0..1 | BackboneElement | Product Part Additional Information
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
component | Σ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
ManufacturedItemDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.status | required | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology` From this IG
ManufacturedItemDefinition.unitOfPresentation | example | UnitOfPresentation `http://hl7.org/fhir/ValueSet/unit-of-presentation` From the FHIR Standard
ManufacturedItemDefinition.ingredient | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
ManufacturedItemDefinition.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.property:OvrRelsMech.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.property:CoatInd.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:CapClass.value[x] | required | PqcmcCapsuleClassificationCategory `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category` From this IG
ManufacturedItemDefinition.property:CapConCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.value[x] | required | PqcmcStrengthTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology` From this IG
ManufacturedItemDefinition.property:TotWgtNum.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtTxt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:QualStd.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:QualStd.value[x] | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
ManufacturedItemDefinition.property:Sterile.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.type.coding | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:weight.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.amount:percent.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:weight.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.location.coding | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` From this IG
ManufacturedItemDefinition.component.constituent.function:Category | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
ManufacturedItemDefinition.component.constituent.function:Function | required | PqcmcExcipientFunctionTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology` From this IG
ManufacturedItemDefinition.component.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.component.property:RelsMech.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x] | required | PqcmcCoatingPurpose `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose` From this IG
ManufacturedItemDefinition.component.property:Color.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-amount-ratio-or-quantity | error | ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent | The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 ) |
cmc-arbitrary-unit-text-required | error | ManufacturedItemDefinition | BR - Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists()) |
cmc-capsule-classification-required | error | ManufacturedItemDefinition | when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists()) |
cmc-capsule-count-required | error | ManufacturedItemDefinition | Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists()) |
cmc-coating-indication-required | error | ManufacturedItemDefinition | Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists()) |
cmc-component-id-ref | error | ManufacturedItemDefinition | If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() ) |
cmc-ingredient-functions | error | ManufacturedItemDefinition.component.constituent | If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2 |
cmc-tablet-bead-count-required | error | ManufacturedItemDefinition | Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists()) |
cmc-tablet-layer-count-required | error | ManufacturedItemDefinition | Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists()) |
dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | ManufacturedItemDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 31 elements(23 nested mandatory elements)
Must-Support: 85 elements

Structures

This structure refers to these other structures:

- Analysis Graphic (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment)
- Attached Document (PDF) (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-pdf-attachment)
- SimpleQuantity (http://hl7.org/fhir/StructureDefinition/SimpleQuantity)
- Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)
- Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
- Drug Product Component (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio (Modifier)
- http://hl7.org/fhir/StructureDefinition/originalText

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of ManufacturedItemDefinition.property (Closed)
- The element 1 is sliced based on the value of ManufacturedItemDefinition.component.amount
- The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.amount
- The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.function (Closed)
- The element 1 is sliced based on the value of ManufacturedItemDefinition.component.property (Closed)

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ManufacturedItemDefinition | C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..1 | Identifier | Unique identifier
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name | S Σ | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
Slices for property | S Σ | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept
property:OvrRelsProf | S Σ | 1..1 | BackboneElement | Product Overall Release Profile
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Profile
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech | S Σ | 0..1 | BackboneElement | Product Overall Release Mechanism
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Mechanism
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd | S Σ | 0..1 | BackboneElement | Product Coating Indicator
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Indicator
value[x] | S Σ | 1..1 | boolean | A value for the characteristic
property:LayCnt | S Σ | 0..1 | BackboneElement | Product Tablet Layer Count
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Layer Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:BeaTypCnt | S Σ | 0..1 | BackboneElement | Tablet Bead Type Count
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Bead Type Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:CapClass | S Σ | 0..1 | BackboneElement | Capsule Shell Part Classification Category
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Classification Category
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt | S Σ | 0..1 | BackboneElement | Product Capsule Constituent Count
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Constituent Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:Schematic | S Σ | 1..* | BackboneElement | Product Schematic
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Schematic
value[x] | S Σ | 1..1 | GraphicAttachment, PDFAttachment | A value for the characteristic
property:WgtTyp | S Σ | 1..1 | BackboneElement | Product Weight Type
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Weight Type
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum | S Σ | 1..1 | BackboneElement | Product Total Weight Numeric Numerator
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (extensible)
comparator | ?!S Σ | 0..1 | code | Product Total Weight Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
property:TotWgtDen | S Σ | 0..1 | BackboneElement | Product Total Weight Numeric Denominator
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator
value[x] | S Σ | 1..1 | SimpleQuantity | A value for the characteristic Binding: Units Of Measure (extensible)
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
property:TotWgtTxt | S Σ | 0..1 | BackboneElement | Product Total Weight Textual
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Total Weight Textual
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
property:QualStd | S Σ | 1..* | BackboneElement | Product Quality Standard
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Quality Standard
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile | S Σ | 1..1 | BackboneElement | Sterile Product Indicator
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Sterile Product Indicator
value[x] | S Σ | 1..1 | boolean | A value for the characteristic
component | S Σ C | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup Constraints: cmc-amount-ratio-or-quantity
Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | ?!S Σ | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
type | S Σ | 1..1 | CodeableConcept | Product Part Type
coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Product Part Type Terminology (required)
function | S Σ | 0..* | CodeableConceptTextOnly | Product Part Function Description
Slices for amount | S Σ | 1..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S Σ | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S Σ | 1..1 | decimal | Product Part Total Weight Numeric
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Total Weight Numeric UOM
code | Σ C | 0..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S Σ | 1..1 | decimal | Product Part Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Content Percent UOM
code | Σ C | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S Σ C | 1..* | BackboneElement | Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:textualStrength | S | 0..1 | (Complex) | Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/StructureDefinition/originalText"
value[x] |  | 1..1 | string | Textual Strength
Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | ?!S Σ | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
Slices for amount | S Σ | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S Σ | 0..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value | S Σ | 1..1 | decimal | Product Part Ingredient Amount Numeric
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Ingredient Amount Numeric UOM
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value | S Σ | 1..1 | decimal | Product Part Ingredient Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Ingredient Content Percent UOM
code | Σ C | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location
coding | S Σ | 1..1 | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text | S Σ | 0..1 | string | Plain text representation of the concept
Slices for function | S Σ | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category | S Σ | 1..1 | CodeableConcept | The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function | S Σ | 0..1 | CodeableConcept | Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient | S Σ | 1..1 | LiteralCodeableReference(Drug Product Component) {b} | The ingredient that is the constituent of the given component
Slices for property | S Σ | 2..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept
property:PPiD | S Σ | 1..1 | BackboneElement | Product Part Identifier
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:PPiDref | S Σ | 0..1 | BackboneElement | Product Part Identifier Reference
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:RelsProf | S Σ | 1..1 | BackboneElement | Product Part Release Profile
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Profile
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech | S Σ | 0..1 | BackboneElement | Product Part Release Mechanism
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Mechanism
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose | S Σ | 0..* | BackboneElement | Coating Product Part Purpose
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Product Part Purpose
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color | S Σ | 0..1 | BackboneElement | Product Part Color Description
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Color Description
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:AddInfo | S Σ | 0..1 | BackboneElement | Product Part Additional Information
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
ManufacturedItemDefinition.status | required | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology` From this IG
ManufacturedItemDefinition.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.property:OvrRelsMech.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.property:CoatInd.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:CapClass.value[x] | required | PqcmcCapsuleClassificationCategory `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category` From this IG
ManufacturedItemDefinition.property:CapConCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.value[x] | required | PqcmcStrengthTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology` From this IG
ManufacturedItemDefinition.property:TotWgtNum.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtTxt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:QualStd.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:QualStd.value[x] | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
ManufacturedItemDefinition.property:Sterile.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.type.coding | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:weight.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.amount:percent.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:weight.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.location.coding | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` From this IG
ManufacturedItemDefinition.component.constituent.function:Category | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
ManufacturedItemDefinition.component.constituent.function:Function | required | PqcmcExcipientFunctionTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology` From this IG
ManufacturedItemDefinition.component.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.component.property:RelsMech.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x] | required | PqcmcCoatingPurpose `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose` From this IG
ManufacturedItemDefinition.component.property:Color.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-amount-ratio-or-quantity | error | ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent | The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 ) |
cmc-arbitrary-unit-text-required | error | ManufacturedItemDefinition | BR - Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists()) |
cmc-capsule-classification-required | error | ManufacturedItemDefinition | when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists()) |
cmc-capsule-count-required | error | ManufacturedItemDefinition | Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists()) |
cmc-coating-indication-required | error | ManufacturedItemDefinition | Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists()) |
cmc-component-id-ref | error | ManufacturedItemDefinition | If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() ) |
cmc-ingredient-functions | error | ManufacturedItemDefinition.component.constituent | If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2 |
cmc-tablet-bead-count-required | error | ManufacturedItemDefinition | Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists()) |
cmc-tablet-layer-count-required | error | ManufacturedItemDefinition | Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists()) |
dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | ManufacturedItemDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

Differential View

This structure is derived from ManufacturedItemDefinition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ManufacturedItemDefinition | C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref
identifier | S | 0..1 | Identifier | Unique identifier
status | S | 1..1 | code | draft | active | retired | unknown
name | S | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm |  | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
Slices for property | S | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
type | S | 1..1 | CodeableConcept | A code expressing the type of characteristic
text | S | 1..1 | string | Plain text representation of the concept
property:OvrRelsProf | S | 1..1 | BackboneElement | Product Overall Release Profile
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Profile
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech | S | 0..1 | BackboneElement | Product Overall Release Mechanism
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Mechanism
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd | S | 0..1 | BackboneElement | Product Coating Indicator
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Indicator
value[x] | S | 1..1 | boolean | A value for the characteristic
property:LayCnt | S | 0..1 | BackboneElement | Product Tablet Layer Count
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Layer Count
value[x] | S | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S | 1..1 | decimal | Numerical value (with implicit precision)
property:BeaTypCnt | S | 0..1 | BackboneElement | Tablet Bead Type Count
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Bead Type Count
value[x] | S | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S | 1..1 | decimal | Numerical value (with implicit precision)
property:CapClass | S | 0..1 | BackboneElement | Capsule Shell Part Classification Category
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Classification Category
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt | S | 0..1 | BackboneElement | Product Capsule Constituent Count
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Constituent Count
value[x] | S | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
value | S | 1..1 | decimal | Numerical value (with implicit precision)
property:Schematic | S | 1..* | BackboneElement | Product Schematic
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Schematic
value[x] | S | 1..1 | GraphicAttachment, PDFAttachment | A value for the characteristic
property:WgtTyp | S | 1..1 | BackboneElement | Product Weight Type
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Weight Type
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum | S | 1..1 | BackboneElement | Product Total Weight Numeric Numerator
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator
value[x] | S | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (extensible)
comparator | S | 0..1 | code | Product Total Weight Operator
property:TotWgtDen | S | 0..1 | BackboneElement | Product Total Weight Numeric Denominator
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator
value[x] | S | 1..1 | SimpleQuantity | A value for the characteristic Binding: Units Of Measure (extensible)
value | S | 1..1 | decimal | Numerical value (with implicit precision)
property:TotWgtTxt | S | 0..1 | BackboneElement | Product Total Weight Textual
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Total Weight Textual
value[x] | S | 1..1 | markdown | A value for the characteristic
property:QualStd | S | 1..* | BackboneElement | Product Quality Standard
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Quality Standard
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile | S | 1..1 | BackboneElement | Sterile Product Indicator
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Sterile Product Indicator
value[x] | S | 1..1 | boolean | A value for the characteristic
component | S C | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup Constraints: cmc-amount-ratio-or-quantity
Slices for modifierExtension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | S | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
type | S | 1..1 | CodeableConcept | Product Part Type
coding |  | 0..* | Coding | Code defined by a terminology system Binding: Product Part Type Terminology (required)
function | S | 0..* | CodeableConceptTextOnly | Product Part Function Description
Slices for amount | S | 1..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Product Part Total Weight Numeric
unit | S | 1..1 | string | Product Part Total Weight Numeric UOM
code |  | 0..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Product Part Content Percent
unit | S | 1..1 | string | Product Part Content Percent UOM
code |  | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S C | 1..* | BackboneElement | Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:textualStrength | S | 0..1 | (Complex) | Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
value[x] |  | 1..1 | string | Textual Strength
Slices for modifierExtension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | S | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
Slices for amount | S | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S | 0..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Product Part Ingredient Amount Numeric
unit | S | 1..1 | string | Product Part Ingredient Amount Numeric UOM
code | S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S | 1..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Product Part Ingredient Content Percent
unit | S | 1..1 | string | Product Part Ingredient Content Percent UOM
code |  | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S | 0..* | CodeableConcept | Product Part Ingredient Physical Location
coding | S | 1..1 | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text | S | 0..1 | string | Plain text representation of the concept
Slices for function | S | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category | S | 1..1 | CodeableConcept | The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function | S | 0..1 | CodeableConcept | Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient | S | 1..1 | LiteralCodeableReference(Drug Product Component) {b} | The ingredient that is the constituent of the given component
Slices for property | S | 2..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
type | S | 1..1 | CodeableConcept | A code expressing the type of characteristic
text | S | 1..1 | string | Plain text representation of the concept
property:PPiD | S | 1..1 | BackboneElement | Product Part Identifier
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier
value[x] | S | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:PPiDref | S | 0..1 | BackboneElement | Product Part Identifier Reference
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x] | S | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:RelsProf | S | 1..1 | BackboneElement | Product Part Release Profile
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Profile
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech | S | 0..1 | BackboneElement | Product Part Release Mechanism
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Mechanism
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose | S | 0..* | BackboneElement | Coating Product Part Purpose
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Product Part Purpose
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color | S | 0..1 | BackboneElement | Product Part Color Description
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Color Description
value[x] | S | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:AddInfo | S | 0..1 | BackboneElement | Product Part Additional Information
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x] | S | 1..1 | markdown | A value for the characteristic
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology` From this IG
ManufacturedItemDefinition.property:OvrRelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.property:CapClass.value[x] | required | PqcmcCapsuleClassificationCategory `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category` From this IG
ManufacturedItemDefinition.property:WgtTyp.value[x] | required | PqcmcStrengthTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology` From this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:QualStd.value[x] | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
ManufacturedItemDefinition.component.type.coding | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.location.coding | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` From this IG
ManufacturedItemDefinition.component.constituent.function:Category | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
ManufacturedItemDefinition.component.constituent.function:Function | required | PqcmcExcipientFunctionTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology` From this IG
ManufacturedItemDefinition.component.property:RelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.component.property:RelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.component.property:CoatPurpose.value[x] | required | PqcmcCoatingPurpose `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose` From this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-amount-ratio-or-quantity | error | ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent | The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 ) |
cmc-arbitrary-unit-text-required | error | ManufacturedItemDefinition | BR - Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists()) |
cmc-capsule-classification-required | error | ManufacturedItemDefinition | when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists()) |
cmc-capsule-count-required | error | ManufacturedItemDefinition | Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists()) |
cmc-coating-indication-required | error | ManufacturedItemDefinition | Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists()) |
cmc-component-id-ref | error | ManufacturedItemDefinition | If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() ) |
cmc-ingredient-functions | error | ManufacturedItemDefinition.component.constituent | If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2 |
cmc-tablet-bead-count-required | error | ManufacturedItemDefinition | Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists()) |
cmc-tablet-layer-count-required | error | ManufacturedItemDefinition | Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists()) |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ManufacturedItemDefinition | C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..1 | Identifier | Unique identifier
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name | S Σ | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
unitOfPresentation | Σ | 0..1 | CodeableConcept | The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of the item, one of several possible
marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient | Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property | S Σ | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept
value[x] | Σ | 0..1 |  | A value for the characteristic
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueMarkdown |  |  | markdown |
valueAttachment |  |  | Attachment |
valueReference |  |  | Reference(Binary) |
property:OvrRelsProf | S Σ | 1..1 | BackboneElement | Product Overall Release Profile
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Profile
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:OvrRelsMech | S Σ | 0..1 | BackboneElement | Product Overall Release Mechanism
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Overall Release Mechanism
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatInd | S Σ | 0..1 | BackboneElement | Product Coating Indicator
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Indicator
value[x] | S Σ | 1..1 | boolean | A value for the characteristic
property:LayCnt | S Σ | 0..1 | BackboneElement | Product Tablet Layer Count
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Layer Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:BeaTypCnt | S Σ | 0..1 | BackboneElement | Tablet Bead Type Count
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Tablet Bead Type Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:CapClass | S Σ | 0..1 | BackboneElement | Capsule Shell Part Classification Category
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Classification Category
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt | S Σ | 0..1 | BackboneElement | Product Capsule Constituent Count
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Capsule Constituent Count
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Required Pattern: At least the following
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
value |  | 0..1 | decimal | Numerical value (with implicit precision)
comparator |  | 0..1 | code | < | <= | >= | > | ad - how to understand the value
unit |  | 0..1 | string | Unit representation
system |  | 1..1 | uri | System that defines coded unit form Fixed Value: http://unitsofmeasure.org
code |  | 1..1 | code | Coded form of the unit Fixed Value: 1
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:Schematic | S Σ | 1..* | BackboneElement | Product Schematic
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Schematic
value[x] | S Σ | 1..1 | GraphicAttachment, PDFAttachment | A value for the characteristic
property:WgtTyp | S Σ | 1..1 | BackboneElement | Product Weight Type
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Weight Type
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Strength Type Terminology (required)
property:TotWgtNum | S Σ | 1..1 | BackboneElement | Product Total Weight Numeric Numerator
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Numerator
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (extensible)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | Σ | 0..1 | decimal | Numerical value (with implicit precision)
comparator | ?!S Σ | 0..1 | code | Product Total Weight Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:TotWgtDen | S Σ | 0..1 | BackboneElement | Product Total Weight Numeric Denominator
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Total Weight Numeric Denominator
value[x] | S Σ | 1..1 | SimpleQuantity | A value for the characteristic Binding: Units Of Measure (extensible)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Numerical value (with implicit precision)
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit
property:TotWgtTxt | S Σ | 0..1 | BackboneElement | Product Total Weight Textual
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Total Weight Textual
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
property:QualStd | S Σ | 1..* | BackboneElement | Product Quality Standard
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Quality Standard
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Quality Benchmark Terminology (required)
property:Sterile | S Σ | 1..1 | BackboneElement | Sterile Product Indicator
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Sterile Product Indicator
value[x] | S Σ | 1..1 | boolean | A value for the characteristic
component | S Σ C | 1..* | BackboneElement | Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup Constraints: cmc-amount-ratio-or-quantity
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | ?!S Σ | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
type | S Σ | 1..1 | CodeableConcept | Product Part Type
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system Binding: Product Part Type Terminology (required)
text | Σ | 0..1 | string | Plain text representation of the concept
function | S Σ | 0..* | CodeableConceptTextOnly | Product Part Function Description
Slices for amount | S Σ | 1..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S Σ | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Product Part Total Weight Numeric
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Total Weight Numeric UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Product Part Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Content Percent UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S Σ C | 1..* | BackboneElement | Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:textualStrength | S | 0..1 | (Complex) | Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/StructureDefinition/originalText"
value[x] |  | 1..1 | string | Textual Strength
Slices for modifierExtension | ?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:amountRatio | ?!S Σ | 0..1 | Ratio | Amount Ratio URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio
Slices for amount | S Σ | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code
amount:weight | S Σ | 0..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Product Part Ingredient Amount Numeric
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Ingredient Amount Numeric UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | S Σ | 1..1 | decimal | Product Part Ingredient Content Percent
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | S Σ | 1..1 | string | Product Part Ingredient Content Percent UOM
system | Σ C | 0..1 | uri | System that defines coded unit form
code | Σ C | 0..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | S Σ | 1..1 | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text | S Σ | 0..1 | string | Plain text representation of the concept
Slices for function | S Σ | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
function:Category | S Σ | 1..1 | CodeableConcept | The function of this constituent within the component e.g. binder Binding: Drug Product Component Function Category Terminology (required)
function:Function | S Σ | 0..1 | CodeableConcept | Product Part Ingredient Function Binding: Excipient Function Terminology (required)
hasIngredient | S Σ | 1..1 | LiteralCodeableReference(Drug Product Component) {b} | The ingredient that is the constituent of the given component
Slices for property | S Σ | 2..* | BackboneElement | General characteristics of this component Slice: Unordered, Closed by value:type.text
property:All Slices |  |  |  | Content/Rules for all slices
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept
value[x] | Σ | 0..1 |  | A value for the characteristic
valueCodeableConcept |  |  | CodeableConcept |
valueQuantity |  |  | Quantity |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueMarkdown |  |  | markdown |
valueAttachment |  |  | Attachment |
valueReference |  |  | Reference(Binary) |
property:PPiD | S Σ | 1..1 | BackboneElement | Product Part Identifier
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:PPiDref | S Σ | 0..1 | BackboneElement | Product Part Identifier Reference
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Identifier Reference
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:RelsProf | S Σ | 1..1 | BackboneElement | Product Part Release Profile
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Profile
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Profile Terminology (required)
property:RelsMech | S Σ | 0..1 | BackboneElement | Product Part Release Mechanism
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Release Mechanism
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Release Mechanism Terminology (required)
property:CoatPurpose | S Σ | 0..* | BackboneElement | Coating Product Part Purpose
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Coating Product Part Purpose
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Coating Purpose Terminology (required)
property:Color | S Σ | 0..1 | BackboneElement | Product Part Color Description
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Color Description
value[x] | S Σ | 1..1 | CodeableConceptTextOnly | A value for the characteristic
property:AddInfo | S Σ | 0..1 | BackboneElement | Product Part Additional Information
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
coding | Σ | 0..* | Coding | Code defined by a terminology system
text | S Σ | 1..1 | string | Plain text representation of the concept Required Pattern: Product Part Additional Information
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
component | Σ | 0..* | See component (ManufacturedItemDefinition) | A component that this component contains or is made from
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
ManufacturedItemDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.status | required | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm | required | PqcmcManufacturedDoseFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology` From this IG
ManufacturedItemDefinition.unitOfPresentation | example | UnitOfPresentation `http://hl7.org/fhir/ValueSet/unit-of-presentation` From the FHIR Standard
ManufacturedItemDefinition.ingredient | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
ManufacturedItemDefinition.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.property:OvrRelsMech.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.property:CoatInd.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:LayCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:CapClass.value[x] | required | PqcmcCapsuleClassificationCategory `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category` From this IG
ManufacturedItemDefinition.property:CapConCnt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:WgtTyp.value[x] | required | PqcmcStrengthTypeTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology` From this IG
ManufacturedItemDefinition.property:TotWgtNum.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x] | extensible | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:TotWgtTxt.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:QualStd.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:QualStd.value[x] | required | PqcmcQualityBenchmarkTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology` From this IG
ManufacturedItemDefinition.property:Sterile.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.type.coding | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:weight.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.amount:percent.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:weight.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:weight.code | required | PqcmcNonPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.amount:percent.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnits `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` From this IG
ManufacturedItemDefinition.component.constituent.location.coding | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` From this IG
ManufacturedItemDefinition.component.constituent.function:Category | required | PqcmcDrugProductComponentFunctionCategoryTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology` From this IG
ManufacturedItemDefinition.component.constituent.function:Function | required | PqcmcExcipientFunctionTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology` From this IG
ManufacturedItemDefinition.component.property.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:PPiDref.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x] | required | PqcmcReleaseProfile `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile` From this IG
ManufacturedItemDefinition.component.property:RelsMech.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x] | required | PqcmcReleaseMechanism `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism` From this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x] | required | PqcmcCoatingPurpose `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose` From this IG
ManufacturedItemDefinition.component.property:Color.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-amount-ratio-or-quantity | error | ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent | The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 ) |
cmc-arbitrary-unit-text-required | error | ManufacturedItemDefinition | BR - Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type = 'Total Weight Textual' ).exists()) |
cmc-capsule-classification-required | error | ManufacturedItemDefinition | when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.text = 'Capsule Classification Category' ).exists()) |
cmc-capsule-count-required | error | ManufacturedItemDefinition | Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.text = 'Capsule Constituent Count').exists()) |
cmc-coating-indication-required | error | ManufacturedItemDefinition | Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.text = 'Coating Indicator').exists()) |
cmc-component-id-ref | error | ManufacturedItemDefinition | If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( component.select( property.where( type.text = 'Product Part Identifier Reference' ).select(value) ).all( text in %context.component.select( property.where( type.text = 'Product Part Identifier' ).select(value.text) ) ) and component.where( property.where( type.text = 'Product Part Identifier Reference' ).select(value.text) = property.where( type.text = 'Product Part Identifier' ).select(value.text) ).exists().not() ) |
cmc-ingredient-functions | error | ManufacturedItemDefinition.component.constituent | If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists() implies function.coding.code.count() = 2 |
cmc-tablet-bead-count-required | error | ManufacturedItemDefinition | Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Bead Type Count' ).exists()) |
cmc-tablet-layer-count-required | error | ManufacturedItemDefinition | Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.text = 'Tablet Layer Count' ).exists()) |
dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | ManufacturedItemDefinition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 31 elements(23 nested mandatory elements)
Must-Support: 85 elements

Structures

This structure refers to these other structures:

- Analysis Graphic (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment)
- Attached Document (PDF) (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-pdf-attachment)
- SimpleQuantity (http://hl7.org/fhir/StructureDefinition/SimpleQuantity)
- Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)
- Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
- Drug Product Component (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio (Modifier)
- http://hl7.org/fhir/StructureDefinition/originalText

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of ManufacturedItemDefinition.property (Closed)
- The element 1 is sliced based on the value of ManufacturedItemDefinition.component.amount
- The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.amount
- The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.function (Closed)
- The element 1 is sliced based on the value of ManufacturedItemDefinition.component.property (Closed)

Maturity: 2

Other representations of profile: CSV, Excel, Schematron