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 MedicinalProductDefinition: Batch Formula Drug Product Identification 2 layer

Generated Narrative: MedicinalProductDefinition f0f3ff35-5cfa-6617-b8f1-b8167957f53c

identifier: ASPIRIN-ACETAMINOPHEN-Identification

combinedPharmaceuticalDoseForm: TABLET, MULTILAYER

route: ORAL

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

name

productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg

type: Non-Proprietary

part

part: ASPIRIN

type: scientific name

part

part: 200mg

type: ASPIRIN

part

part: ACETAMINOPHEN

type: scientific name

part

part: 300mg

type: ACETAMINOPHEN