Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2 United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Example Bundle: 3.2.P.4 Bundle

Document Content

32P40

Additional Resources Included in Document

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:

identifier: Cochineal

classification: Chemical

grade: Company Standard

Codes

-Code
*TZ8Z31B35M

Names

-NameTypePreferred
*CochinealGSRS Preferred Termtrue

SourceMaterials

-TypeGenusSpeciesCountryOfOrigin
*ChemicalDactylopiuscochinealTurkey

Entry 4 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a

Resource Organization:

identifier: DUNS/143265222

name: Wunderwerke

Contacts

-Address
*Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478