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 2-layer batch formula ingredient - Water

Generated Narrative: Ingredient 95648837-ec81-42d9-970c-eac390f2f604

identifier: WaterBFIngredient

status: Active

role: Inactive Ingredient

substance

Codes

-Reference
*Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

strength

concentration: 50.75 kilogram (Details: UCUM codekg = 'kg')

strength

concentration: 95.3572 percent (Details: UCUM code% = '%')