IngredComponentSubstance example showing the use of the sourceMaterial backbone element - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v1.0.0-ballot

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

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

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "496f83ad-2365-4b12-8672-a349d99f7d67"

Profile: Component Substance

identifier: Grape skin extract

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

grade: BP (PQ-CMC-FDA Temporary Codes#C176793)

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

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

Codes

Code

3GOV20705G (Unique Ingredient Identifier (UNII)#3GOV20705G)

Names

Name

Type

Preferred

WINE GRAPE

GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)

true

SourceMaterials

Type

Genus

Species

Part

CountryOfOrigin

Plant (PQ-CMC-FDA Temporary Codes#C14258)

Vitis ()

vinifera ()

skin ()

United States of America (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#USA)