StructureDefinition-pqcmc-product-batch-formula

Sourcehl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0)
resourceTypeStructureDefinition
idpqcmc-product-batch-formula
canonicalhttp://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-product-batch-formula
version0.1.15
statusdraft
publisherHL7 International - Biomedical Research and Regulatory WG
nameBatchFormula
titleDrug Product Batch Formula
date2023-07-17T03:00:13+00:00
descriptionListing 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.
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 optional user designated identifier
. . . status S
. . . name S 1.. Product Non-proprietary Name
. . . manufacturer S Reference (Manufacturing and/or Test Site Organization)
. . . Slices for property S 2 .. Slice: Unordered, Closed by value:type
. . . . property:BatchSize S 1..1
. . . . . type S Batch Quantity
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: batchsize
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Batch Quantity
. . . . . value[x] Quantity
. . . . . . unit S 1.. Quantity UOM
. . . . . . code S 1.. Binding: Units Of Measure Terminology ( required )
. . . . property:BatchUtil S 1..*
. . . . . 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: BatchUtil
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Batch Utilization
. . . . . value[x] S 1.. CodeableConcept Batch Utilization
. . . . . . coding Binding: Batch utilization Terminology ( required )
. . . . property:AddInfo 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: batchinfo
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Batch Formula Additional Information
. . . . . value[x] markdown Batch Formula Additional Information
. . . component S 1..
. . . . type S Product Part Type
. . . . constituent S 1..
. . . . . Slices for extension Slice: Unordered, Open by value:url
. . . . . additional-info S 0..1 markdown Drug Product Constituent Additional Information
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-additional-info-extension
. . . . . formulaIngredient S 0..1 (Complex) Product Batch Ingredient Extension
URL: http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pq-product-batch-ingredient-extension
. . . . . Slices for amount S 1 .. 2 Slice: Unordered, Closed by value:code
. . . . . . amount:Weight S C 1..1 cmc-percent-quantity: The component.constituent('Weight').amount.code from PqcmcUnitsMeasureTerminology cannot be VolumeToVolume, WeightToVolume or WeightToWeight
. . . . . . . value S 1.. Ingredient Quanty Per Batch Product Part
. . . . . . . unit S 1..
. . . . . . . code S 1.. Binding: Units Of Measure Terminology ( required )
. . . . . . amount:VolumeToVolume S 0..1
. . . . . . . value S 1.. Percent Ingredient Quanty Per Batch Product Part
. . . . . . . code 1.. Required Pattern: C48571
. . . . . . amount:WeightToVolume S 0..1
. . . . . . . value S 1.. Percent Ingredient Quanty Per Batch Product Part
. . . . . . . code 1.. Required Pattern: C48527
. . . . . . amount:WeightToWeight S 0..1
. . . . . . . value S 1.. Percent Ingredient Quanty Per Batch Product Part
. . . . . . . code 1.. Required Pattern: C48528
. . . . . location S Percent Product Part Ingredient Physical Location
. . . . . . coding Binding: Product Part Ingredient Physical Location value set ( required )
. . . . . hasIngredient S 1..1 CodeableReference (Drug Product Batch Formula Ingredient)
. . . . property S ..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: info
. . . . . . . display 1..1 string Representation defined by the system
Fixed Value: Product Part Additional Information
. . . . . value[x] markdown Drug Product Component Additional Information
. . . . component S

doco Documentation for this format

Produced 08 Sep 2023