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 SubstanceDefinition: IngredComponentSubstance example showing the use of the sourceMaterial backbone element

Generated Narrative: SubstanceDefinition 496f83ad-2365-4b12-8672-a349d99f7d67

identifier: Grape skin extract

classification: Mixture

grade: BP

manufacturer: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000

supplier: Bundle: identifier = UUID:32532fe8-1bfb-4a0a-998d-9294742a9519; type = document; timestamp = 2024-06-19 21:06:21+0000

Codes

-Code
*3GOV20705G

Names

-NameTypePreferred
*WINE GRAPEGSRS Preferred Termtrue

SourceMaterials

-TypeGenusSpeciesPartCountryOfOrigin
*PlantVitisviniferaskinUnited States of America