Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Example Composition: eCTD Product Specification Composition SP4151

Generated Narrative: Composition

Resource Composition "d332acdf-4874-407b-9950-528f14c6bea2"

Profile: eCTD Specification Composition

identifier: ExampleSpecification

status: final

type: Quality Specification (Code System PQCMC Comp Section Types#SP4151)

date: 2023-12-15 22:33:13+0000

author: urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a

title: Quality Specification for an example Drug Product