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 - IBUPROFEN

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "580c28ac-1a2c-49fa-9be3-de997da5edcf"

Profile: Routine Drug Substance

identifier: P-Isobutylhydratropic Acid

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

supplier: urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049

Codes

-Code
*WK2XYI10QM (Unique Ingredient Identifier (UNII)#WK2XYI10QM)

Names

-NameTypePreferred
*IBUPROFENPIRINGSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)true