Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2 United States of America flag

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 1.1.2 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 Composition: Substance Characterization for EthylAcetate

Generated Narrative: Composition

ResourceComposition "d52acdbd-6881-495a-84a2-0dccf07ee5ab"

Profile: eCTD Substance Characterisation

identifier: EthylAcetate -- Characterization Composition

status: final

type: Substance Characterisation (Code System PQCMC Comp Section Types#32S3)

date: 2024-06-19 21:06:21+0000

author: urn:uuid:48beec35-843c-42f5-9251-7aa6fd693199

title: Substance Characterization for EthylAcetate