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: Strength info for the Active Ingredient

Generated Narrative: Ingredient fc09842a-8f71-48f2-9f9f-ff2441b2eb6f

status: Draft

role: Active Ingredient

substance

Codes

-Reference
*Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000

strength

Strength Extension: Mass

concentration: 200 milligram (Details: UCUM codemg = 'mg')/1 arbitrary unit (Details: UCUM code[arb'U] = '[arb'U]')

textConcentration: 200mg

strength

concentration: 16.65 percent (Details: UCUM code% = '%')