Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI United States of America flag

Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions

Example SubstanceDefinition: Example SubstanceDefinition for Carrageenan

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "d8242262-2187-4ea2-907f-b66752202b46"

Profile: Excipient Drug Substance

identifier: Carrageenan

classification: Structurally Diverse Substance - Herbal (Dummy EMA Codesystem#9)

grade: Company Standard (Dummy NCIT Codesystem#C134009)

manufacturer: urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579

Codes

-Code
*5C69YCD2YJ (gsrs.ncats.nih.gov#5C69YCD2YJ)

Names

-NameTypePreferred
*CarrageenanGSRS Preferred Term (Dummy NCIT Codesystem#C203355)true

SourceMaterials

-TypeGenusSpeciesCountryOfOrigin
*Plant (Dummy NCIT Codesystem#C14258)palmaria ()palmata ()United States of America (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#USA)