Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 1.0.0-ballot 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

Example MedicinalProductDefinition: A DrugProductContainerClosure

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "77ad6922-9c59-43d1-93cb-29d063cc2e8c"

Profile: Drug Product Container Closure

Container Closure

url

containerType

value: BOTTLE (PQ-CMC-FDA Temporary Codes#C43169)

url

closureType

value: Child-resistant, Plastic (PQ-CMC-FDA Temporary Codes#C96114)

url

description

value: a plastic bottle with a child-proof cap

name

productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg

type: Non-Proprietary (Product Name Types Code Types#NON)

part

part: ASPIRIN

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 200mg

type: strength name (EntityNamePartQualifierR2#STR)

part

part: ACETAMINOPHEN

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 300mg

type: strength name (EntityNamePartQualifierR2#STR)