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sushi-config.yaml
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sushi-config.yaml
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id: hl7.fhir.us.pq-cmc-fda
canonical: http://hl7.org/fhir/us/pq-cmc-fda
name: FHIR_pqcmc_fda
title: "Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA"
description: "The FDA PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls. This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review."
status: active
license: CC0-1.0 #https://www.hl7.org/fhir/valueset-spdx-license.html
version: 1.0.0
fhirVersion: 5.0.0
copyrightYear: 2021+
releaseLabel: STU1
extension:
- url: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
valueCode: brr
publisher:
name: HL7 International / Biomedical Research and Regulation
url: 'http://www.hl7.org/Special/committees/rcrim'
email: [email protected]
jurisdiction: urn:iso:std:iso:3166#US "United States of America"
dependencies:
hl7.terminology.r5: 5.5.0
menu:
Table of Contents: toc.html
Home: index.html
General Instructions: instruction.html
eCTD Profiles Stage 1:
General Information (3.2.S.1): eCTD32S10.html
Control of Materials (3.2.S.2.3): eCTD32S23.html
Specification (3.2.S.4.1, 3.2.P.4 & 3.2.P.5.1): eCTDSP4151.html
Description and Composition of the Drug Product (3.2.P.1): eCTD32P10.html
# eCTD Profiles Stage 2:
# Substance Characterisation (3.2.S.3): eCTD32S3.html
# Product Batch Formula (3.2.P.3.2): eCTD32P32.html
# Product Characterisation of Impurities (3.2.P.5.5): eCTD32P55.html
# DRAFT eCTD Profiles:
# Product Container Closure System (3.2.P.7.0): eCTD32P70.html
# Substance Container Closure System (3.2.S.6.0): eCTD32S60.html
# Batch Analyses (3.2.S.4.4 & 3.2.P.5.4): eCTDSP4454.html
# Stability Summary (3.2.S.7.1 & 3.2.P.8.1): eCTDSP7181.html
# Stability Data (3.2.S.7.3 & 3.2.P.8.3): eCTDSP7383.html
Artifacts: artifacts.html
Downloads: downloads.html
Change Notes: change_notes.html
pages:
index.html:
title: "Home"
generation: markdown
instruction.html:
title: "General Instructions"
generation: markdown
eCTD32S10.html:
title: "General Information (3.2.S.1)"
generation: markdown
eCTD32S23.html:
title: "Substance Control of Materials (3.2.S.2.3)"
generation: markdown
# eCTD32S3.md:
# title: "Substance Characterisation (3.2.S.3)"
# generation: markdown
eCTDSP4151.html:
title: "Specification (3.2.S.4.1, 3.2.P.4 and 3.2.P.5.1)"
generation: markdown
eCTD32P10.html:
title: "Description and Composition of the Drug Product (3.2.P.1)"
generation: markdown
# eCTD32P32.md:
# title: "Product Batch Formula (3.2.P.3.2)"
# generation: markdown
# eCTD32P55.md:
# title: "Product Characterisation of Impurities (3.2.P.5.5)"
# generation: markdown
artifacts.html:
title: "Artifact List"
downloads.html:
title: "Downloads"
generation: markdown
change_notes.html:
title: "Change Notes"
generation: markdown
parameters:
releaselabel: true
excludettl: true
excludemap: true
apply-wg: true
jira-code: pq-cmc
# {joint-iso-itu-t(2) country(16) us(840) organization(1) hl7(113883)}
auto-oid-root: 2.16.840.1.113883.4.642.40.36
special-url: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
- https://www.uniprot.org
- urn:oid:1.3.6.1.4.1.5193
- http://unitsofmeasure.org
- urn:oid:1.3.6.1.4.1.519.1
- urn:oid:2.16.840.1.113883.4.82
- https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site
- urn:ietf:rfc:3986
# validation: [allow-any-extensions, no-broken-links]