Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon 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 1.1.6 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 batch formula ingredient substance - MANNITOL

Generated Narrative: SubstanceDefinition a339a562-e325-4ce6-a830-d25c27b5e2da

classification: Chemical

grade: USP-NF

Codes

-Code
*3OWL53L36A

Names

-NameTypePreferred
*MANNITOLGSRS Preferred Termtrue

SourceMaterials

-Type
*Chemical