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 SubstanceDefinition: Example RoutineSubstanceDefinition for Asprin

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "cd84a8b5-4e96-551c-15c6-c97c943eb38a"

Profile: Routine Drug Substance

identifier: salicylate

classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)

grade: USP-NF (PQ-CMC-FDA Temporary Codes#C134006)

manufacturer: urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5

Codes

-Code
*R16CO5Y76E (Unique Ingredient Identifier (UNII)#R16CO5Y76E)

name

name: ACETYLSALICYLIC ACID

type: Generic Name (PQ-CMC-FDA Temporary Codes#C97054)

name

name: ASPIRIN

type: GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)

preferred: true