Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
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
Document Details
Profile: CMC eCTD SP4151 Document
Final Document at 2023-12-15 22:36:51+0000 by Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 for
Document Content
Entry 2 - fullUrl = urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93
Resource PlanDefinition:
Id: cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93 Version: 1.0 ExampleSpecification2
Title: Quality Specification for an API 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: C134022
display: Drug Substance
Subject: reference: urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf
Date: 2022-12-08 Approval Date: 2022-12-08 Actions:
Single Stage Microbiological Examination of Nonsterile Products:
Then:
Staphylococcus aureus:
Pseudomonas aeruginosa:
Bacillus subtilis:
Total Aerobic Microbial Count (TAMC):
Total Yeasts and Molds Count (TYMC):
Entry 3 - fullUrl = urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf
Resource SubstanceDefinition:
Profile: Drug Substance Handle
identifier: P-Isobutylhydratropic Acid
classification: Chemical
grade: USP-NF
manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000
Codes
Code WK2XYI10QM Names
Name Type Preferred IBUPROFENPIRIN GSRS Preferred Term true
Entry 4 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a
Resource Organization:
Profile: Basic Organization
identifier: DUNS/143265222
name: Wunderwerke
Contacts
Address Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
Entry 5 - fullUrl = urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5
Resource Organization:
Profile: Basic Organization
identifier: DUNS/143265222, FEI/6981397
name: Vidinaid
Contacts
Address Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA
Entry 6 - fullUrl = urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049
Resource Organization:
Profile: Basic Organization
identifier: DUNS/173265332
name: Mega Chem Supply
Contacts
Address Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0 based on FHIR 5.0.0. Generated 2025-07-08
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