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: Drug Product Batch Formula

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: BatchFormula
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.47

Listing of all components of the dosage form to be used in the manufacture, their amounts on a per batch basis, including overages, and reference to their quality standards.

Usages:

- Use this Profile: CMC eCTD 32P32 Document
- Refer to this Profile: Batch Formula Drug Product Identification

### 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 |  | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
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 | optional user designated identifier
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name | S Σ | 1..1 | string | Product Non-proprietary Name
manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
manufacturer | S Σ | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible
Slices for property | S Σ | 2..* | 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:BatchSize | S Σ | 1..1 | BackboneElement | Batch Quantity
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: Batch Quantity
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required)
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.
code | Σ C | 0..1 | code | Quantity UOM
property:BatchUtil | S Σ | 1..* | BackboneElement | Batch Utilization
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: Batch Utilization
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo | S Σ | 0..1 | BackboneElement | Batch Formula 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: Batch Formula Additional Information
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
component | S Σ | 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
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required)
Slices for amount | Σ | 2..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, Closed by value:code
amount:perBatch | S Σ | 1..1 | Quantity | Component Quantity Per Batch
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 | S Σ | 1..1 | string | Unit representation
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 total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
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 | S Σ | 1..1 | string | Unit representation
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S Σ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:additional-info | S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
extension:ingredientOverage | S C | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension Constraints: cmc-overage-percent-limit
extension:StrengthTextual | S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Slices for amount | S Σ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:perBatch | S Σ | 1..1 | Quantity | Component Quantity Per Batch
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 | S Σ | 1..1 | string | Unit representation
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | Quantity Percent
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 | S Σ | 1..1 | string | Unit representation
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
hasIngredient | S Σ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component
Slices for property | S Σ | 1..* | 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: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
component | S 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.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:BatchSize.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology` From this IG
ManufacturedItemDefinition.property:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.type | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:perBatch.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.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:perBatch.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.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 | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` 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:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-overage-percent-limit | error | ManufacturedItemDefinition.component.constituent.extension:ingredientOverage | Overage percent must be less than 1.0 : extension.where(url='proportionDecimal').single().value < 1 |
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 |  |  | ManufacturedItemDefinition |
identifier | S | 0..1 | Identifier | optional user designated identifier
status | S | 1..1 | code | draft | active | retired | unknown
name | S | 1..1 | string | Product Non-proprietary Name
manufacturedDoseForm |  | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
manufacturer | S | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible
Slices for property | S | 2..* | 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:BatchSize | S | 1..1 | BackboneElement | Batch Quantity
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Quantity
value[x] | S | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required)
value | S | 1..1 | decimal | Numerical value (with implicit precision)
code |  | 0..1 | code | Quantity UOM
property:BatchUtil | S | 1..* | BackboneElement | Batch Utilization
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Utilization
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo | S | 0..1 | BackboneElement | Batch Formula Additional Information
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Formula Additional Information
value[x] | S | 1..1 | markdown | A value for the characteristic
component | S | 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
type | S | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required)
Slices for amount |  | 2..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, Closed by value:code
amount:perBatch | S | 1..1 | Quantity | Component Quantity Per Batch
value | S | 1..1 | decimal | Numerical value (with implicit precision)
unit | S | 1..1 | string | Unit representation
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 total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Numerical value (with implicit precision)
unit | S | 1..1 | string | Unit representation
code | S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:additional-info | S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
extension:ingredientOverage | S | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
extension:StrengthTextual | S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
Slices for amount | S | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:perBatch | S | 1..1 | Quantity | Component Quantity Per Batch
value | S | 1..1 | decimal | Numerical value (with implicit precision)
unit | S | 1..1 | string | Unit representation
code | S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S | 1..1 | Quantity | Quantity Percent
value | S | 1..1 | decimal | Numerical value (with implicit precision)
unit | S | 1..1 | string | Unit representation
code | S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
hasIngredient | S | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component
Slices for property | S | 1..* | 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: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
component | S | 0..* |  | A component that this component contains or is made from
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:BatchSize.value[x] | required | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology` From this IG
ManufacturedItemDefinition.component.type | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:perBatch.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:perBatch.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 | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` From this IG

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ManufacturedItemDefinition |  | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
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 | optional user designated identifier
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name | S Σ | 1..1 | string | 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 | S Σ | 0..* | LiteralReference(Basic Organization) {b} | 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 | 2..* | 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:BatchSize | S Σ | 1..1 | BackboneElement | Batch Quantity
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: Batch Quantity
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required)
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 | Quantity UOM
property:BatchUtil | S Σ | 1..* | BackboneElement | Batch Utilization
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: Batch Utilization
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo | S Σ | 0..1 | BackboneElement | Batch Formula 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: Batch Formula Additional Information
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
component | S Σ | 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
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 | Product Part Type Binding: Product Part Type Terminology (required)
function | Σ | 0..* | CodeableConcept | The function of this component within the item e.g. delivers active ingredient, masks taste
Slices for amount | Σ | 2..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, Closed by value:code
amount:perBatch | S Σ | 1..1 | Quantity | Component Quantity Per Batch
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 | S Σ | 1..1 | string | Unit representation
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 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 | 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 | S Σ | 1..1 | string | Unit representation
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: Percentage Units (required)
constituent | S Σ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:additional-info | S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
extension:ingredientOverage | S C | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension Constraints: cmc-overage-percent-limit
extension:StrengthTextual | S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Slices for amount | S Σ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:perBatch | S Σ | 1..1 | Quantity | Component Quantity Per Batch
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 | S Σ | 1..1 | string | Unit representation
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 | Quantity Percent
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 | S Σ | 1..1 | string | Unit representation
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: Percentage Units (required)
location | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
function | Σ | 0..* | CodeableConcept | The function of this constituent within the component e.g. binder
hasIngredient | S Σ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component
Slices for property | S Σ | 1..* | 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: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 | S 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:BatchSize.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology` From this IG
ManufacturedItemDefinition.property:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.type | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:perBatch.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.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:perBatch.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.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 | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` 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:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-overage-percent-limit | error | ManufacturedItemDefinition.component.constituent.extension:ingredientOverage | Overage percent must be less than 1.0 : extension.where(url='proportionDecimal').single().value < 1 |
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: 30 elements(3 nested mandatory elements)
Must-Support: 49 elements

Structures

This structure refers to these other structures:

- Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
- Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
- Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
- Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)
- Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
- http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
- http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension

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 (Closed)
- The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.amount (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 |  | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
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 | optional user designated identifier
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name | S Σ | 1..1 | string | Product Non-proprietary Name
manufacturedDoseForm | Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
manufacturer | S Σ | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible
Slices for property | S Σ | 2..* | 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:BatchSize | S Σ | 1..1 | BackboneElement | Batch Quantity
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: Batch Quantity
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required)
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.
code | Σ C | 0..1 | code | Quantity UOM
property:BatchUtil | S Σ | 1..* | BackboneElement | Batch Utilization
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: Batch Utilization
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo | S Σ | 0..1 | BackboneElement | Batch Formula 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: Batch Formula Additional Information
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
component | S Σ | 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
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | S Σ | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required)
Slices for amount | Σ | 2..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, Closed by value:code
amount:perBatch | S Σ | 1..1 | Quantity | Component Quantity Per Batch
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 | S Σ | 1..1 | string | Unit representation
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 total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
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 | S Σ | 1..1 | string | Unit representation
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S Σ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:additional-info | S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
extension:ingredientOverage | S C | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension Constraints: cmc-overage-percent-limit
extension:StrengthTextual | S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Slices for amount | S Σ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:perBatch | S Σ | 1..1 | Quantity | Component Quantity Per Batch
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 | S Σ | 1..1 | string | Unit representation
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S Σ | 1..1 | Quantity | Quantity Percent
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 | S Σ | 1..1 | string | Unit representation
code | S Σ C | 1..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
hasIngredient | S Σ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component
Slices for property | S Σ | 1..* | 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: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
component | S 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.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:BatchSize.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology` From this IG
ManufacturedItemDefinition.property:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.type | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:perBatch.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.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:perBatch.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.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 | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` 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:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-overage-percent-limit | error | ManufacturedItemDefinition.component.constituent.extension:ingredientOverage | Overage percent must be less than 1.0 : extension.where(url='proportionDecimal').single().value < 1 |
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 |  |  | ManufacturedItemDefinition |
identifier | S | 0..1 | Identifier | optional user designated identifier
status | S | 1..1 | code | draft | active | retired | unknown
name | S | 1..1 | string | Product Non-proprietary Name
manufacturedDoseForm |  | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required)
manufacturer | S | 0..* | LiteralReference(Basic Organization) {b} | Manufacturer of the item, one of several possible
Slices for property | S | 2..* | 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:BatchSize | S | 1..1 | BackboneElement | Batch Quantity
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Quantity
value[x] | S | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required)
value | S | 1..1 | decimal | Numerical value (with implicit precision)
code |  | 0..1 | code | Quantity UOM
property:BatchUtil | S | 1..* | BackboneElement | Batch Utilization
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Utilization
value[x] | S | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo | S | 0..1 | BackboneElement | Batch Formula Additional Information
type |  |  |  |
text |  | 1..1 | string | Plain text representation of the concept Required Pattern: Batch Formula Additional Information
value[x] | S | 1..1 | markdown | A value for the characteristic
component | S | 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
type | S | 1..1 | CodeableConcept | Product Part Type Binding: Product Part Type Terminology (required)
Slices for amount |  | 2..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, Closed by value:code
amount:perBatch | S | 1..1 | Quantity | Component Quantity Per Batch
value | S | 1..1 | decimal | Numerical value (with implicit precision)
unit | S | 1..1 | string | Unit representation
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 total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
value | S | 1..1 | decimal | Numerical value (with implicit precision)
unit | S | 1..1 | string | Unit representation
code | S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required)
constituent | S | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:additional-info | S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
extension:ingredientOverage | S | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
extension:StrengthTextual | S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
Slices for amount | S | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:perBatch | S | 1..1 | Quantity | Component Quantity Per Batch
value | S | 1..1 | decimal | Numerical value (with implicit precision)
unit | S | 1..1 | string | Unit representation
code | S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required)
amount:percent | S | 1..1 | Quantity | Quantity Percent
value | S | 1..1 | decimal | Numerical value (with implicit precision)
unit | S | 1..1 | string | Unit representation
code | S | 1..1 | code | Coded form of the unit Binding: Percentage Units (required)
location | S | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
hasIngredient | S | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component
Slices for property | S | 1..* | 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: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
component | S | 0..* |  | A component that this component contains or is made from
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:BatchSize.value[x] | required | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology` From this IG
ManufacturedItemDefinition.component.type | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:perBatch.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:perBatch.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 | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` From this IG

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
ManufacturedItemDefinition |  | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
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 | optional user designated identifier
status | ?!S Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name | S Σ | 1..1 | string | 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 | S Σ | 0..* | LiteralReference(Basic Organization) {b} | 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 | 2..* | 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:BatchSize | S Σ | 1..1 | BackboneElement | Batch Quantity
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: Batch Quantity
value[x] | S Σ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (required)
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 | Quantity UOM
property:BatchUtil | S Σ | 1..* | BackboneElement | Batch Utilization
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: Batch Utilization
value[x] | S Σ | 1..1 | CodeableConcept | A value for the characteristic Binding: Batch utilization Terminology (required)
property:AddInfo | S Σ | 0..1 | BackboneElement | Batch Formula 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: Batch Formula Additional Information
value[x] | S Σ | 1..1 | markdown | A value for the characteristic
component | S Σ | 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
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 | Product Part Type Binding: Product Part Type Terminology (required)
function | Σ | 0..* | CodeableConcept | The function of this component within the item e.g. delivers active ingredient, masks taste
Slices for amount | Σ | 2..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, Closed by value:code
amount:perBatch | S Σ | 1..1 | Quantity | Component Quantity Per Batch
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 | S Σ | 1..1 | string | Unit representation
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 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 | 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 | S Σ | 1..1 | string | Unit representation
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: Percentage Units (required)
constituent | S Σ | 1..* | BackboneElement | A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:additional-info | S | 0..1 | markdown | Drug Product Constituent Additional Information URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
extension:ingredientOverage | S C | 0..1 | (Complex) | Overage Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension Constraints: cmc-overage-percent-limit
extension:StrengthTextual | S | 0..1 | string | Product Batch Strength Textual Extension URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Slices for amount | S Σ | 2..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Closed by value:code
amount:perBatch | S Σ | 1..1 | Quantity | Component Quantity Per Batch
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 | S Σ | 1..1 | string | Unit representation
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 | Quantity Percent
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 | S Σ | 1..1 | string | Unit representation
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: Percentage Units (required)
location | S Σ | 0..* | CodeableConcept | Product Part Ingredient Physical Location Binding: Ingredient Location Terminology (required)
function | Σ | 0..* | CodeableConcept | The function of this constituent within the component e.g. binder
hasIngredient | S Σ | 1..1 | LiteralCodeableReference(Drug Product Batch Formula Ingredient) {b} | The ingredient that is the constituent of the given component
Slices for property | S Σ | 1..* | 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: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 | S 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:BatchSize.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BatchSize.value[x] | required | PqcmcUnitsMeasure `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` From this IG
ManufacturedItemDefinition.property:BatchSize.value[x].comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.property:BatchUtil.value[x] | required | PqcmcBatchUtilizationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology` From this IG
ManufacturedItemDefinition.property:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard
ManufacturedItemDefinition.component.type | required | PqcmcProductPartType `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` From this IG
ManufacturedItemDefinition.component.amount:perBatch.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.amount:perBatch.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:perBatch.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` From the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount:perBatch.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 | required | PqcmcProductPartIngredientPhysicalLocation `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` 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:AddInfo.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmc-overage-percent-limit | error | ManufacturedItemDefinition.component.constituent.extension:ingredientOverage | Overage percent must be less than 1.0 : extension.where(url='proportionDecimal').single().value < 1 |
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: 30 elements(3 nested mandatory elements)
Must-Support: 49 elements

Structures

This structure refers to these other structures:

- Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
- Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
- Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
- Drug Product Batch Formula Ingredient (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient)
- Text Only Codeable Concept (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
- http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
- http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension

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

Maturity: 2

Other representations of profile: CSV, Excel, Schematron