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 Ingredient: Example batch formula ingredient - Mannitol

Generated Narrative: Ingredient 29c0ee76-f62f-41d3-b761-73d5f205e552

identifier: MannitolBFIngredient

status: Active

role: Inactive Ingredient

substance

Codes

-Reference
*Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

strength

concentration: 2.27 kilogram (Details: UCUM codekg = 'kg')

strength

concentration: 4.2652 percent (Details: UCUM code% = '%')