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, 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 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

## Example Bundle: 3.2.S.4.1 Bundle

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

## 32S41

## Additional Resources Included in Document

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

> supplier: 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