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 - Acetic Acid

Generated Narrative: Ingredient 12cce82f-8595-4860-b7ca-06c9ec0327f2

identifier: GlacialAceticAcidBFIngredient

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: 20.5 gram (Details: UCUM codeg = 'g')

strength

concentration: 0.0385 percent (Details: UCUM code% = '%')