Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2
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 2.0.0-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
Document Content
Entry 1 - fullUrl = urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4
Resource Composition:
Generated Narrative: Composition 4bd1ed57-852b-42be-a9b0-355f8a2aa7d4
identifier: CochinealSpecificationComposition
status: Final
type: Control of Excipients
date: 2024-01-01 19:42:35+0000
title: Cochineal specification Composition Example
Entry 2 - fullUrl = urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e
Resource PlanDefinition:
Id: 37bf5cc0-33bf-478b-b84e-ccb35143ef6e Version: 1.0 CochinealSpecification
Title: Cochineal specification Example Type: system: http://terminology.hl7.org/CodeSystem/plan-definition-type
code: workflow-definition
display: Workflow Definition
system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code: C133931
display: Raw Materials/Excipients/Intermediates/Reagents
Subject: reference: urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf
Date: 2023-12-01 Actions:
Single Stage Appearance:
Single Stage Identification:
Single Stage pH:
Single Stage Residue on Ignition:
Single Stage Impurities:
Then:
Unidentified Impurities:
Then: Additional sub-actions not displayed
Entry 3 - fullUrl = urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition 278736ef-2ddf-49e4-895c-3a9f34db36cf
identifier: Cochineal
classification: Chemical
grade: Company Standard
Codes
Code TZ8Z31B35M Names
Name Type Preferred Cochineal GSRS Preferred Term true SourceMaterials
Type Genus Species CountryOfOrigin Chemical Dactylopius cochineal Turkey
Entry 4 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a
Resource Organization:
Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a
identifier: DUNS/143265222
name: Wunderwerke
Contacts
Address Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-12
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