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 Composition: Cochineal specification Composition Example

Generated Narrative: Composition

Resource Composition "4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"

Profile: eCTD Specification Composition

identifier: CochinealSpecificationComposition

status: final

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

date: 2024-01-01 19:42:35+0000

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

title: Cochineal specification Composition Example