Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
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 1.1.6 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
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part | Version: 1.1.6 | |||
| Active as of 2024-09-22 | Computable Name: FinishedProduct | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.29 | ||||
The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ManufacturedItemDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ManufacturedItemDefinition |
C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself |
  meta |
||||
  profile |
S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
 identifier |
S | 0..1 | Identifier | Unique identifier |
| status |
S | 1..1 | code | draft | active | retired | unknown |
| name |
S | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name |
| manufacturedDoseForm |
||||
| coding |
0..* | Coding | Code defined by a terminology system Binding: Manufactured Dose Form Terminology (required) | |
 Slices for property |
S | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type |
  property:OvrRelsProf |
S | 1..1 | BackboneElement | General characteristics of this item |
  type |
S | 1..1 | CodeableConcept | Product Overall Release Profile Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
   coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
 system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: OvrRelsProf | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Overall Release Profile | |
 Slices for value[x] |
1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Open by type:$this | |
 value[x]:valueCodeableConcept |
S | 1..1 | CodeableConcept | A value for the characteristic |
 coding |
0..* | Coding | Code defined by a terminology system Binding: Release Profile Terminology (required) | |
| property:OvrRelsMech |
S | 0..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Overall Release Mechanism Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: OvrRelsMech | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Overall Release Mechanism | |
| Slices for value[x] |
1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Open by type:$this | |
| value[x]:valueCodeableConcept |
S | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
0..* | Coding | Code defined by a terminology system Binding: Release Mechanism Terminology (required) | |
| property:CoatInd |
S | 0..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Coating Indicator Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: CoatInd | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Coating Indicator | |
| Slices for value[x] |
1..1 | boolean | A value for the characteristic Slice: Unordered, Open by type:$this | |
 value[x]:valueBoolean |
S | 1..1 | boolean | A value for the characteristic |
| property:LayCnt |
S | 0..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Tablet Layer Count Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: TabLayCnt | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Tablet Layer Count | |
 value[x] |
S | 1..1 | Quantity | A value for the characteristic |
| unit |
0..1 | string | Unit representation Required Pattern: 1* | |
| system |
0..1 | uri | System that defines coded unit form Required Pattern: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
0..1 | code | Coded form of the unit Required Pattern: C66832 | |
| property:BeaTypCnt |
S | 0..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Tablet Bead Type Count Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: BeaTypCnt | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Tablet Bead Type Count | |
| value[x] |
S | 1..1 | Quantity | A value for the characteristic |
| unit |
0..1 | string | Unit representation Required Pattern: 1* | |
| system |
0..1 | uri | System that defines coded unit form Required Pattern: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
0..1 | code | Coded form of the unit Required Pattern: C66832 | |
| property:CapClass |
S | 0..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Capsule Shell Part Classification Category Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: CapClass | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Capsule Classification Category | |
| Slices for value[x] |
1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Open by type:$this | |
| value[x]:valueCodeableConcept |
S | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
0..* | Coding | Code defined by a terminology system Binding: Capsule Shell Classification Terminology (required) | |
| property:CapConCnt |
S | 0..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Capsule Constituent Count Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: CapConCnt | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Capsule Constituent Count | |
| value[x] |
S | 1..1 | Quantity | A value for the characteristic |
| unit |
0..1 | string | Unit representation Required Pattern: 1* | |
| system |
0..1 | uri | System that defines coded unit form Required Pattern: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
0..1 | code | Coded form of the unit Required Pattern: C66832 | |
| property:Schematic |
S | 1..* | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Schematic Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Schematic | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Schematic | |
| Slices for value[x] |
1..1 | Attachment | A value for the characteristic Slice: Unordered, Open by type:$this | |
| value[x]:valueAttachment |
S | 1..1 | Attachment | A value for the characteristic |
| property:WgtTyp |
S | 1..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Weight Type Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: WgtTyp | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Weight Type | |
| Slices for value[x] |
1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Open by type:$this | |
| value[x]:valueCodeableConcept |
S | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
0..* | Coding | Code defined by a terminology system Binding: Strength Type Terminology (required) | |
| property:TotWgtNum |
S | 1..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Total Weight Numeric Numerator Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: TotWgtNum | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Total Weight Numeric Numerator | |
| value[x] |
S | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (extensible) |
| comparator |
S | 0..1 | code | Product Total Weight Operator |
| property:TotWgtDen |
S | 0..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Total Weight Numeric Denominator Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: TotWgtDen | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Total Weight Numeric Denominator | |
| value[x] |
S | 1..1 | SimpleQuantity | A fixed quantity (no comparator) |
| code |
0..1 | code | Coded form of the unit Binding: Units Of Measure (extensible) | |
| property:TotWgtTxt |
S | 0..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Total Weight Textual Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: TotWgtTxt | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Total Weight Textual | |
 value[x] |
S | 1..1 | markdown | A value for the characteristic |
| property:QualStd |
S | 1..* | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Product Quality Standard Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: QualStd | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Quality Standard | |
| Slices for value[x] |
1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Open by type:$this | |
| value[x]:valueCodeableConcept |
S | 1..1 | CodeableConcept | A value for the characteristic Binding: Quality Benchmark Terminology (required) |
| property:Sterile |
S | 1..1 | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | Sterile Product Indicator Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Sterile | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Sterile Product Indicator | |
| value[x] |
S | 1..1 | boolean | A value for the characteristic |
| component |
SC | 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 cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive |
 Slices for modifierExtension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| modifierExtension:amountRatio |
S | 0..1 | AmountRatio | Amount Ratio |
| type |
S | 1..1 | CodeableConcept | Product Part Type |
| coding |
0..* | Coding | Code defined by a terminology system Binding: Product Part Type Terminology (required) | |
| function |
||||
| text |
S | 0..1 | string | Product Part Function Description |
| Slices for amount |
S | 0..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code |
| amount:weight |
S | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) |
 value |
S | 1..1 | decimal | Product Part Total Weight Numeric |
| unit |
S | 1..1 | string | Product Part Total Weight Numeric UOM |
| code |
0..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) | |
| amount:percent |
S | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) |
| value |
S | 1..1 | decimal | Product Part Content Percent |
| unit |
S | 1..1 | string | Product Part Content Percent UOM |
| code |
0..1 | code | Coded form of the unit Binding: Percentage Units (required) | |
| constituent |
SC | 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) cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive |
 Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| textualStrength |
S | 0..1 | (Complex) | Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText |
| value[x] |
1..1 | string | Textual Strength | |
| Slices for modifierExtension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| modifierExtension:amountRatio |
S | 0..1 | AmountRatio | Amount Ratio |
| Slices for amount |
S | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code |
| amount:weight |
S | 1..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) |
| value |
S | 1..1 | decimal | Product Part Ingredient Amount Numeric |
| unit |
S | 1..1 | string | Product Part Ingredient Amount Numeric UOM |
| code |
S | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
| amount:percent |
S | 0..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) |
| value |
S | 1..1 | decimal | Product Part Ingredient Content Percent |
| unit |
S | 1..1 | string | Product Part Ingredient Content Percent UOM |
| code |
0..1 | code | Coded form of the unit Binding: Percentage Units (required) | |
| location |
S | 0..* | CodeableConcept | Product Part Ingredient Physical Location |
| coding |
S | 1..1 | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required) |
| text |
S | 0..1 | string | Plain text representation of the concept |
| Slices for function |
S | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:coding |
| function:All Slices |
Content/Rules for all slices | |||
| coding |
S | 1..1 | Coding | Code defined by a terminology system |
| function:Category |
S | 1..1 | CodeableConcept | Product Part Ingredient Component Function Category |
| coding |
0..* | Coding | Code defined by a terminology system Binding: Drug Product Component Function Category Terminology (required) | |
| function:Function |
S | 0..1 | CodeableConcept | Product Part Ingredient Function |
| coding |
0..* | Coding | Code defined by a terminology system Binding: Excipient Function Terminology (required) | |
 hasIngredient |
S | 1..1 | CodeableReference(Drug Product Component) | The ingredient that is the constituent of the given component |
| Slices for property |
S | 2..* | General characteristics of this component Slice: Unordered, Closed by value:type | |
| property:PPiD |
S | 1..1 | BackboneElement | General characteristics of this component |
| type |
S | 1..1 | CodeableConcept | A code expressing the type of characteristic Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiD | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier | |
| value[x] |
S | 1..1 | CodeableConcept | A value for the characteristic |
| text |
S | 1..1 | string | Product Part Identifier |
| property:PPiDref |
S | 0..1 | BackboneElement | General characteristics of this component |
| type |
S | 1..1 | CodeableConcept | A code expressing the type of characteristic Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiDref | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier Reference | |
| value[x] |
S | 1..1 | CodeableConcept | A value for the characteristic |
| text |
S | 1..1 | string | Product Part Identifier Reference |
| property:RelsProf |
S | 1..1 | BackboneElement | General characteristics of this component |
| type |
S | 1..1 | CodeableConcept | Product Part Release Profile Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: RelsProf | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Part Release Profile | |
| value[x] |
S | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
0..* | Coding | Code defined by a terminology system Binding: Release Profile Terminology (required) | |
| property:RelsMech |
S | 0..1 | BackboneElement | General characteristics of this component |
| type |
1..1 | CodeableConcept | Product Part Release Mechanism Required Pattern: At least the following | |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: RelsMech | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Part Release Mechanism | |
| value[x] |
S | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
0..* | Coding | Code defined by a terminology system Binding: Release Mechanism Terminology (required) | |
| property:CoatPurpose |
S | 0..* | BackboneElement | General characteristics of this component |
| type |
S | 1..1 | CodeableConcept | Coating Product Part Purpose Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: CoatPurpose | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Coating Product Part Purpose | |
| value[x] |
S | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
0..* | Coding | Code defined by a terminology system Binding: Coating Purpose Terminology (required) | |
| property:Color |
S | 0..1 | BackboneElement | General characteristics of this component |
| type |
S | 1..1 | CodeableConcept | Product Part Color Description Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Color | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Part Color Description | |
| value[x] |
S | 1..1 | CodeableConcept | A value for the characteristic |
| text |
S | 1..1 | string | Plain text representation of the concept |
| property:AddInfo |
S | 0..1 | BackboneElement | General characteristics of this component |
| type |
S | 1..1 | CodeableConcept | Product Part Additional Information Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: AddInfo | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Part Additional Information | |
| value[x] |
0..1 | markdown | A value for the characteristic | |
| component |
S | 0..* | A component that this component contains or is made from | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| ManufacturedItemDefinition.manufacturedDoseForm.coding | required | PqcmcManufacturedDoseFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminologyfrom this IG | |
| ManufacturedItemDefinition.property:OvrRelsProf.type | required | Pattern: OvrRelsProf("Product Overall Release Profile")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding | required | PqcmcReleaseProfilehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profilefrom this IG | |
| ManufacturedItemDefinition.property:OvrRelsMech.type | required | Pattern: OvrRelsMech("Product Overall Release Mechanism")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding | required | PqcmcReleaseMechanismhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanismfrom this IG | |
| ManufacturedItemDefinition.property:CoatInd.type | required | Pattern: CoatInd("Coating Indicator")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:LayCnt.type | required | Pattern: TabLayCnt("Tablet Layer Count")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:BeaTypCnt.type | required | Pattern: BeaTypCnt("Tablet Bead Type Count")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:CapClass.type | required | Pattern: CapClass("Capsule Classification Category")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding | required | PqcmcCapsuleClassificationCategoryhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-categoryfrom this IG | |
| ManufacturedItemDefinition.property:CapConCnt.type | required | Pattern: CapConCnt("Capsule Constituent Count")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:Schematic.type | required | Pattern: Schematic("Product Schematic")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:WgtTyp.type | required | Pattern: WgtTyp("Product Weight Type")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding | required | PqcmcStrengthTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminologyfrom this IG | |
| ManufacturedItemDefinition.property:TotWgtNum.type | required | Pattern: TotWgtNum("Product Total Weight Numeric Numerator")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:TotWgtNum.value[x] | extensible | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measurefrom this IG | |
| ManufacturedItemDefinition.property:TotWgtDen.type | required | Pattern: TotWgtDen("Product Total Weight Numeric Denominator")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:TotWgtDen.value[x].code | extensible | PqcmcUnitsMeasurehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measurefrom this IG | |
| ManufacturedItemDefinition.property:TotWgtTxt.type | required | Pattern: TotWgtTxt("Total Weight Textual")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:QualStd.type | required | Pattern: QualStd("Quality Standard")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept | required | PqcmcQualityBenchmarkTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminologyfrom this IG | |
| ManufacturedItemDefinition.property:Sterile.type | required | Pattern: Sterile("Sterile Product Indicator")http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristicfrom this IG | |
| ManufacturedItemDefinition.component.type.coding | required | PqcmcProductPartTypehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-typefrom this IG | |
| ManufacturedItemDefinition.component.amount:weight.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| ManufacturedItemDefinition.component.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-unitsfrom this IG | |
| ManufacturedItemDefinition.component.constituent.amount:weight.code | required | PqcmcNonPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-unitsfrom this IG | |
| ManufacturedItemDefinition.component.constituent.amount:percent.code | required | PqcmcPercentageUnitshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-unitsfrom this IG | |
| ManufacturedItemDefinition.component.constituent.location.coding | required | PqcmcProductPartIngredientPhysicalLocationhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-locationfrom this IG | |
| ManufacturedItemDefinition.component.constituent.function:Category.coding | required | PqcmcDrugProductComponentFunctionCategoryTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminologyfrom this IG | |
| ManufacturedItemDefinition.component.constituent.function:Function.coding | required | PqcmcExcipientFunctionTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminologyfrom this IG | |
| ManufacturedItemDefinition.component.property:RelsProf.value[x].coding | required | PqcmcReleaseProfilehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profilefrom this IG | |
| ManufacturedItemDefinition.component.property:RelsMech.value[x].coding | required | PqcmcReleaseMechanismhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanismfrom this IG | |
| ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding | required | PqcmcCoatingPurposehttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purposefrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| cmc-amount-ratio-or-quantity | error | ManufacturedItemDefinition.component, ManufacturedItemDefinition.component.constituent | The amount ratio extension and an amount with a non-percentage unit are mutually exclusive : defineVariable('system','http://unitsofmeasure.org').select( modifierExtension.where(url = 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-amount-ratio') .union( amount.where( system = %system and code.memberOf('http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units') ) ).count() = 1 ) | |
| cmc-arbitrary-unit-text-required | error | ManufacturedItemDefinition | BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : defineVariable('system','http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').select( property.where( type.coding.exists( system = %system and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = %system and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = %system ) ).exists()) | |
| cmc-capsule-classification-required | error | ManufacturedItemDefinition | when the the dosage form is 'capsule' and a 'capsule shell' part
exists, a capsule shell part classification is mandatory : defineVariable('system','http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154433' ) and component.type.coding.exists( system = %system and code = 'C203897' ) implies property.where( type.coding.exists( system = %system and code = 'CapClass' ) ).exists()) | |
| cmc-capsule-count-required | error | ManufacturedItemDefinition | Capsule constituent count is required when the dosage form is 'Capsule' : defineVariable('system','http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').select( manufacturedDoseForm.coding.exists(system = %system and code = 'C154433') implies property.where(type.coding.exists(system = %system and code = 'CapConCnt')).exists()) | |
| cmc-coating-indication-required | error | ManufacturedItemDefinition | Coating indication is required when the dosage form is a tablet, lozenge or capsule : defineVariable('system','http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').select( manufacturedDoseForm.coding.exists(system = %system and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = %system and code = 'CoatInd')).exists()) | |
| cmc-component-id-ref | error | ManufacturedItemDefinition | If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself : defineVariable('system','http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').select( component.select( property.where( type.coding.exists( system = %system and code = 'PPiDref' ) ).select(value) ).all( text in %context.component.select( property.where( type.coding.exists( system = %system and code = 'PPiD' ) ).select(value.text) ) ) and component.where( property.where( type.coding.exists( system = %system and code = 'PPiDref' ) ).select(value.text) = property.where( type.coding.exists( system = %system and code = 'PPiD' ) ).select(value.text) ).exists().not() ) | |
| cmc-ingredient-functions | error | ManufacturedItemDefinition.component.constituent | If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable.
If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies function.coding.code.count() = 2 | |
| cmc-tablet-bead-count-required | error | ManufacturedItemDefinition | Tablet bead count is required when the dosage form is a tablet : defineVariable('system','http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').select(manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.coding.exists( system = %system and code = 'BeaTypCnt' ) ).exists()) | |
| cmc-tablet-layer-count-required | error | ManufacturedItemDefinition | Tablet layer count is required when the dosage form is a tablet : defineVariable('system','http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').select( manufacturedDoseForm.coding.exists( system = %system and code = 'C154605' ) implies property.where( type.coding.exists( system = %system and code = 'TabLayCnt' ) ).exists()) |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ManufacturedItemDefinition |
C | 0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself |
| meta |
Σ | 0..1 | Meta | Metadata about the resource |
| profile |
SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| 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 |
SΣ | 0..1 | Identifier | Unique identifier |
| status |
?!SΣ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. |
| name |
SΣ | 0..1 | string | Product Proprietary Name | Product Non-proprietary Name |
| manufacturedDoseForm |
Σ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary. |
| coding |
Σ | 0..* | Coding | Code defined by a terminology system Binding: Manufactured Dose Form Terminology (required) |
| Slices for property |
SΣ | 6..* | BackboneElement | General characteristics of this item Slice: Unordered, Closed by value:type |
| property:All Slices |
Content/Rules for all slices | |||
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
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. |
| property:OvrRelsProf |
SΣ | 1..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Overall Release Profile Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: OvrRelsProf | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Overall Release Profile | |
| Slices for value[x] |
Σ | 1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Closed by type:$this |
| value[x]:valueCodeableConcept |
SΣ | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
Σ | 0..* | Coding | Code defined by a terminology system Binding: Release Profile Terminology (required) |
| property:OvrRelsMech |
SΣ | 0..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Overall Release Mechanism Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: OvrRelsMech | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Overall Release Mechanism | |
| Slices for value[x] |
Σ | 1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Closed by type:$this |
| value[x]:valueCodeableConcept |
SΣ | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
Σ | 0..* | Coding | Code defined by a terminology system Binding: Release Mechanism Terminology (required) |
| property:CoatInd |
SΣ | 0..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Coating Indicator Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: CoatInd | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Coating Indicator | |
| Slices for value[x] |
Σ | 1..1 | boolean | A value for the characteristic Slice: Unordered, Closed by type:$this |
| value[x]:valueBoolean |
SΣ | 1..1 | boolean | A value for the characteristic |
| property:LayCnt |
SΣ | 0..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Tablet Layer Count Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: TabLayCnt | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Tablet Layer Count | |
| value[x] |
SΣ | 1..1 | Quantity | A value for the characteristic |
| 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 Required Pattern: 1* |
| system |
ΣC | 0..1 | uri | System that defines coded unit form Required Pattern: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy |
| code |
ΣC | 0..1 | code | Coded form of the unit Required Pattern: C66832 |
| property:BeaTypCnt |
SΣ | 0..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Tablet Bead Type Count Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: BeaTypCnt | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Tablet Bead Type Count | |
| value[x] |
SΣ | 1..1 | Quantity | A value for the characteristic |
| 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 Required Pattern: 1* |
| system |
ΣC | 0..1 | uri | System that defines coded unit form Required Pattern: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy |
| code |
ΣC | 0..1 | code | Coded form of the unit Required Pattern: C66832 |
| property:CapClass |
SΣ | 0..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Capsule Shell Part Classification Category Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: CapClass | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Capsule Classification Category | |
| Slices for value[x] |
Σ | 1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Closed by type:$this |
| value[x]:valueCodeableConcept |
SΣ | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
Σ | 0..* | Coding | Code defined by a terminology system Binding: Capsule Shell Classification Terminology (required) |
| property:CapConCnt |
SΣ | 0..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Capsule Constituent Count Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: CapConCnt | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Capsule Constituent Count | |
| value[x] |
SΣ | 1..1 | Quantity | A value for the characteristic |
| 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 Required Pattern: 1* |
| system |
ΣC | 0..1 | uri | System that defines coded unit form Required Pattern: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy |
| code |
ΣC | 0..1 | code | Coded form of the unit Required Pattern: C66832 |
| property:Schematic |
SΣ | 1..* | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Schematic Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Schematic | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Schematic | |
| Slices for value[x] |
Σ | 1..1 | Attachment | A value for the characteristic Slice: Unordered, Closed by type:$this |
| value[x]:valueAttachment |
SΣ | 1..1 | Attachment | A value for the characteristic |
| property:WgtTyp |
SΣ | 1..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Weight Type Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: WgtTyp | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Weight Type | |
| Slices for value[x] |
Σ | 1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Closed by type:$this |
| value[x]:valueCodeableConcept |
SΣ | 1..1 | CodeableConcept | A value for the characteristic |
| coding |
Σ | 0..* | Coding | Code defined by a terminology system Binding: Strength Type Terminology (required) |
| property:TotWgtNum |
SΣ | 1..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Total Weight Numeric Numerator Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: TotWgtNum | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Total Weight Numeric Numerator | |
| value[x] |
SΣ | 1..1 | Quantity | A value for the characteristic Binding: Units Of Measure (extensible) |
| comparator |
?!SΣ | 0..1 | code | Product Total Weight Operator Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
| property:TotWgtDen |
SΣ | 0..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Total Weight Numeric Denominator Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: TotWgtDen | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Total Weight Numeric Denominator | |
| value[x] |
SC | 1..1 | SimpleQuantity | A fixed quantity (no comparator) qty-3: If a code for the unit is present, the system SHALL also be present sqty-1: The comparator is not used on a SimpleQuantity |
| code |
ΣC | 0..1 | code | Coded form of the unit Binding: Units Of Measure (extensible) |
| property:TotWgtTxt |
SΣ | 0..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Total Weight Textual Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: TotWgtTxt | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Total Weight Textual | |
| value[x] |
SΣ | 1..1 | markdown | A value for the characteristic |
| property:QualStd |
SΣ | 1..* | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Quality Standard Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: QualStd | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Quality Standard | |
| Slices for value[x] |
Σ | 1..1 | CodeableConcept | A value for the characteristic Slice: Unordered, Closed by type:$this |
| value[x]:valueCodeableConcept |
SΣ | 1..1 | CodeableConcept | A value for the characteristic Binding: Quality Benchmark Terminology (required) |
| property:Sterile |
SΣ | 1..1 | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Sterile Product Indicator Binding: PQCMC Product Characteristic (required) Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: Sterile | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Sterile Product Indicator | |
| value[x] |
SΣ | 1..1 | boolean | A value for the characteristic |
| component |
SΣC | 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 cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive |
| Slices for modifierExtension |
?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url |
| modifierExtension:amountRatio |
?!S | 0..1 | AmountRatio | Amount Ratio |
| type |
SΣ | 1..1 | CodeableConcept | Product Part Type |
| coding |
Σ | 0..* | Coding | Code defined by a terminology system 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 |
| text |
SΣ | 0..1 | string | Product Part Function Description |
| Slices for amount |
SΣ | 0..2 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code |
| amount:weight |
SΣ | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) |
| value |
SΣ | 1..1 | decimal | Product Part Total Weight Numeric |
| comparator |
?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
| unit |
SΣ | 1..1 | string | Product Part Total Weight Numeric UOM |
| code |
ΣC | 0..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
| amount:percent |
SΣ | 0..1 | Quantity | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) |
| value |
SΣ | 1..1 | decimal | Product Part Content Percent |
| comparator |
?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
| unit |
SΣ | 1..1 | string | Product Part Content Percent UOM |
| code |
ΣC | 0..1 | code | Coded form of the unit Binding: Percentage Units (required) |
| constituent |
SΣC | 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) cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| textualStrength |
S | 0..1 | (Complex) | Original Text that represents the data as seen/selected/uttered originally URL: http://hl7.org/fhir/StructureDefinition/originalText |
| extension |
0..0 | |||
| url |
1..1 | uri | "http://hl7.org/fhir/StructureDefinition/originalText" | |
| value[x] |
1..1 | string | Textual Strength | |
| Slices for modifierExtension |
?!Σ | 0..* | Extension | Extension Slice: Unordered, Open by value:url |
| modifierExtension:amountRatio |
?!S | 0..1 | AmountRatio | Amount Ratio |
| Slices for amount |
SΣ | 1..2 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code |
| amount:weight |
SΣ | 1..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) |
| value |
SΣ | 1..1 | decimal | Product Part Ingredient Amount Numeric |
| comparator |
?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
| unit |
SΣ | 1..1 | string | Product Part Ingredient Amount Numeric UOM |
| code |
SΣC | 1..1 | code | Coded form of the unit Binding: Non-Percentage Units (required) |
| amount:percent |
SΣ | 0..1 | Quantity | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) |
| value |
SΣ | 1..1 | decimal | Product Part Ingredient Content Percent |
| comparator |
?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
| unit |
SΣ | 1..1 | string | Product Part Ingredient Content Percent UOM |
| code |
ΣC | 0..1 | code | Coded form of the unit Binding: Percentage Units (required) |
| location |
SΣ | 0..* | CodeableConcept | Product Part Ingredient Physical Location |
| coding |
SΣ | 1..1 | Coding | Code defined by a terminology system Binding: Ingredient Location Terminology (required) |
| text |
SΣ | 0..1 | string | Plain text representation of the concept |
| Slices for function |
SΣ | 1..2 | CodeableConcept | The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:coding |
| function:All Slices |
Content/Rules for all slices | |||
| coding |
SΣ | 1..1 | Coding | Code defined by a terminology system |
| function:Category |
SΣ | 1..1 | CodeableConcept | Product Part Ingredient Component Function Category |
| coding |
Σ | 0..* | Coding | Code defined by a terminology system Binding: Drug Product Component Function Category Terminology (required) |
| function:Function |
SΣ | 0..1 | CodeableConcept | Product Part Ingredient Function |
| coding |
Σ | 0..* | Coding | Code defined by a terminology system Binding: Excipient Function Terminology (required) |
| hasIngredient |
SΣ | 1..1 | CodeableReference(Drug Product Component) | The ingredient that is the constituent of the given component |
| Slices for property |
SΣ | 2..* | See property (ManufacturedItemDefinition) | General characteristics of this component Slice: Unordered, Closed by value:type |
| property:PPiD |
SΣ | 1..1 | BackboneElement | General characteristics of this component |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 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. Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiD | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier | |
| value[x] |
SΣ | 1..1 | CodeableConcept | A value for the characteristic |
| text |
SΣ | 1..1 | string | Product Part Identifier |
| property:PPiDref |
SΣ | 0..1 | BackboneElement | General characteristics of this component |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 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. Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: PPiDref | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Part Identifier Reference | |
| value[x] |
SΣ | 1..1 | CodeableConcept | A value for the characteristic |
| text |
SΣ | 1..1 | string | Product Part Identifier Reference |
| property:RelsProf |
SΣ | 1..1 | BackboneElement | General characteristics of this component |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | Product Part Release Profile Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: RelsProf | |
|