Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 1.0.0-ballot 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: Composition ingredient substance indentifying information - Maize starch

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "393a14e7-3edc-4373-bbe5-9e569d504a1c"

Profile: Component Substance

identifier: Maize starch

classification: Mixture (PQ-CMC-FDA Temporary Codes#C45305)

grade: Company Standard (PQ-CMC-FDA Temporary Codes#C134009)

manufacturer: urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049

supplier: urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9

Codes

-Code
*O8232NY3SJ (Unique Ingredient Identifier (UNII)#O8232NY3SJ)

Names

-NameTypePreferred
*STARCH, CORNGSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)true

SourceMaterials

-TypeGenusSpeciesCountryOfOrigin
*Plant (PQ-CMC-FDA Temporary Codes#C14258)zea ()mays ()Argentina (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#ARG)