StructureDefinition-pqcmc-product-part

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idpqcmc-product-part
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-product-part
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameFinishedProduct
titleManufactured Drug Product
date2023-07-17T03:00:13+00:00
descriptionThe manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or compoent.
jurisdictionsus
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypeManufacturedItemDefinition
derivationconstraint
basehttp://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition
Usages
Name Flags Card. Type Description & Constraints doco
. . ManufacturedItemDefinition ManufacturedItemDefinition
. . . meta
. . . . profile S 1..1
. . . identifier S ..1
. . . status S
. . . name S Product Proprietary name | Product Non-proprietary Name
. . . manufacturedDoseForm
. . . . coding Binding: Pharmaceutical Dosage Form Terminology ( required )
. . . Slices for property S 4 .. Slice: Unordered, Closed by value:type
. . . . property:OvrRelsProf S 1..1
. . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . 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 .. Slice: Unordered, Open by type:$this
. . . . . . value[x]:valueCodeableConcept S 1..1 CodeableConcept Product Overall Release Profile
. . . . . . . coding Binding: Release Profile value set ( required )
. . . . property:OvrRelsMech S 0..1
. . . . . type S Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: OvrRelsMech
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Product Overall Release Mechanism
. . . . . Slices for value[x] 1 .. Slice: Unordered, Open by type:$this
. . . . . . value[x]:valueCodeableConcept S 1..1 CodeableConcept Product Overall Release Mechanism
. . . . . . . coding Binding: Release Mechanism value set ( required )
. . . . property:CoatInd S 1..1
. . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . 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 .. Slice: Unordered, Open by type:$this
. . . . . . value[x]:valueBoolean S 1..1 boolean Coating Indicator
. . . . property:LayCnt S 0..1
. . . . . type S Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: TabLayCnt
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Tablet Layer Count
. . . . . value[x] S 1.. Quantity
. . . . . . value Tablet Layer Count
. . . . . . code Required Pattern: C66832
. . . . property:BeaTypCnt S 0..1
. . . . . type S Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: BeaTypCnt
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Tablet Bead Type Count
. . . . . value[x] S 1.. Quantity
. . . . . . value Tablet Bead Type Count
. . . . . . code Required Pattern: C66832
. . . . property:CapClass S 0..1
. . . . . type S Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: CapClass
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Capsule Classification Category
. . . . . Slices for value[x] 1 .. Slice: Unordered, Open by type:$this
. . . . . . value[x]:valueCodeableConcept S 1..1 CodeableConcept Capsule Classification Category
. . . . . . . coding Binding: Capsule Classification Category Value Set ( required )
. . . . property:CapConCnt S 0..1
. . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . 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.. Quantity
. . . . . . value Capsule Constituent Count
. . . . . . code Required Pattern: C66832
. . . . property:Schematic S 1..*
. . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . 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 .. Slice: Unordered, Open by type:$this
. . . . . . value[x]:valueAttachment S 1..1 Attachment Product Schematic
. . . . property:WgtTyp S 1..1
. . . . . type S Required Pattern: At least the following
. . . . . . coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
. . . . . . . system 1..1 uri Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: WgtTyp
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Product Weight Type
. . . . . Slices for value[x] 1 .. Slice: Unordered, Open by type:$this
. . . . . . value[x]:valueCodeableConcept S 1..1 CodeableConcept Product Weight Type
. . . . . . . coding Binding: Strength Type Terminology ( required )
. . . . property:TotWgtNum S 0..1
. . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . 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.. Quantity
. . . . . . value Product Total Weight Numeric Numerator
. . . . . . code Binding: Units Of Measure Terminology ( required )
. . . . property:TotWgtDen S 0..1
. . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . 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.. Quantity
. . . . . . value Product Total Weight Numeric Denominator
. . . . . . code Binding: Units Of Measure Terminology ( required )
. . . . property:TotWgtTxt S 0..1
. . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . 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.. markdown
. . . . . . value Total Weight Textual
. . . . property:TotWgtOper S 0..1
. . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: TotWgtOper
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Total Weight Operator
. . . . . Slices for value[x] 1 .. Slice: Unordered, Open by type:$this
. . . . . . value[x]:valueCodeableConcept S 1..1 CodeableConcept Total Weight Operator
Binding: Strength Operator Terminology ( required )
. . . component S C 1.. cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child.
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 onstituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.
. . . . type S Product Part Type
. . . . . coding Binding: Product Part Type Value Set ( required )
. . . . function
. . . . . text S Tablet Product Part Function Description
. . . . amount
. . . . . value S 1.. Product Part Total Weight Numeric Numerator
. . . . . unit S 1.. Product Total Weight Numeric Numerator UOM
. . . . . code S 1.. Binding: Units Of Measure Terminology ( required )
. . . . constituent S 1..
. . . . . Slices for extension 1.. Slice: Unordered, Open by value:url
. . . . . ConstituentPercent S 1..1 decimal Constituent Content Percent
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/content-percent
. . . . . amount S ..3
. . . . . . value S 1.. Product Part Ingredient Amount Numeric Numerator
. . . . . . unit S 1.. Product Part Ingredient Amount Numerator UOM
. . . . . . code S 1.. Binding: Units Of Measure Terminology ( required )
. . . . . location S Product Part Ingredient Physical Location
. . . . . . coding S 1..1 Binding: Product Part Ingredient Physical Location value set ( required )
. . . . . . text S
. . . . . Slices for function S 1 .. 2 Slice: Unordered, Closed by value:coding.version
. . . . . . function:All Slices Content/Rules for all slices
. . . . . . . coding S 1..1
. . . . . . function:Category S 1..1 Product Part Ingredient Component Function Category
. . . . . . . coding Binding: Drug Product Component Function Category Terminology ( required )
. . . . . . . . version 1.. Required Pattern: category
. . . . . . function:Function S 0..1 Product Part Ingredient Function
. . . . . . . coding Binding: Excipient Function Terminology ( required )
. . . . . . . . version 1.. Required Pattern: function
. . . . . hasIngredient S 1..1 CodeableReference (Drug Product Component)
. . . . Slices for property S 3 .. Slice: Unordered, Closed by value:type
. . . . . property:PPiD S 1..1 BackboneElement
. . . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . . 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.. CodeableConcept
. . . . . . . coding Product Part Role
Binding: Relationship types Value Set ( required )
. . . . . . . text S 1.. Product Part Identifier
. . . . . property:PPiDref S 0..1 BackboneElement
. . . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . . 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.. CodeableConcept
. . . . . . . text S 1.. Product Part Identifier Reference
. . . . . property:RelsProf S 1..1 BackboneElement
. . . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . . 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.. CodeableConcept Product Part Release Profile
. . . . . . . coding Binding: Release Profile value set ( required )
. . . . . property:RelsMech S 0..1 BackboneElement
. . . . . . type 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . . 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.. CodeableConcept Product Part Release Mechanism
. . . . . . . coding Binding: Release Mechanism value set ( required )
. . . . . property:CoatPurpose S 0..* BackboneElement
. . . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . . 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.. CodeableConcept Coating Product Part Purpose
. . . . . . . coding Binding: Coating Purpose value set ( required )
. . . . . property:Color S 0..1 BackboneElement
. . . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . . 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.. CodeableConcept
. . . . . . . text S 1.. Product Part Color Description
. . . . . property:ContPercent S 1..1 BackboneElement
. . . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . . code 1..1 code Symbol in syntax defined by the system
Fixed Value: ContPercent
. . . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Product Part Content Percent
. . . . . . value[x] S 1.. Quantity Product Part Content Percent
. . . . . property:AddInfo S 0..1 BackboneElement
. . . . . . type S 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
. . . . . . . . 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] markdown Product Part Additional Information
. . . . component S

doco Documentation for this format

Produced 08 Sep 2023