FHIR Document example of 3.2.S.4.1. - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v2.0.0-ballot

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan United States of America flag

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

Example Bundle: FHIR Document example of 3.2.S.4.1.

Document Details

Generated Narrative: Bundle Quality Specification for an API

Document Content

32S41

Additional Resources Included in Document

Entry 1 - fullUrl = urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f

Resource Composition:

Generated Narrative: Composition 55d92f43-e328-4011-bbcf-744e3afd954f

identifier: ExampleSpecification2
status: Final
type: Specification
date: 2023-12-15 22:36:51+0000
author: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000
title: Quality Specification for an API

Entry 2 - fullUrl = urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93

Resource PlanDefinition:

Generated Narrative: PlanDefinition cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93

Specification Status: Tentatively Approved
Additional Information:
This API is is currently characterized through a standard battery of physicochemical characterzation tests.

identifier: ExampleSpecification2
version: 1.0
title: Quality Specification for an API
type: Workflow Definition
status: Active
subject: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000
date: 2022-12-08
approvalDate: 2022-12-08
goal
id
b304ed45-5295-4082-9827-f20e1ff0d1d3
description: Negative
addresses: Release, Stability
Targets
- Detail[x]
* Negative
goal
id
d4e38c52-30f6-4bb7-ab84-99439a7266ce
description: Negative
addresses: Release, Stability
Targets
- Detail[x]
* Negative
goal
id
2abf1f19-e1b1-42e4-b943-79f5fa1642fe
description: Negative
addresses: Release, Stability
Targets
- Detail[x]
* Negative
goal
id
c0ed4a79-8f40-4d26-8845-4cea166fb627
description: NMT 10 colony-forming units
addresses: Release, Stability
Targets
- Detail[x]
* <=10 colony forming unit (Details: UCUM code[CFU] = '[CFU]')
goal
id
442983b5-bbc3-4534-9f1b-5ae5e4c531c1
description: NMT 100 colony-forming units
addresses: Release, Stability
Targets
- Detail[x]
* <=100 colony forming unit (Details: UCUM code[CFU] = '[CFU]')
action
id
997a8ec6-eabf-41a3-b166-ddc3dfb35c27
title: Microbiological Examination of Nonsterile Products
code: Visual
reason: Microbial Limits
Documentations
- Type Label
* Documentation USP <61>
Actions
- LinkId Prefix Title GoalId
* 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 1 Staphylococcus aureus b304ed45-5295-4082-9827-f20e1ff0d1d3
* 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 2 Pseudomonas aeruginosa d4e38c52-30f6-4bb7-ab84-99439a7266ce
* 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 3 Bacillus subtilis 2abf1f19-e1b1-42e4-b943-79f5fa1642fe
* 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 4 Total Aerobic Microbial Count (TAMC) c0ed4a79-8f40-4d26-8845-4cea166fb627
* 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 5 Total Yeasts and Molds Count (TYMC) 442983b5-bbc3-4534-9f1b-5ae5e4c531c1

Entry 3 - fullUrl = urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition 580c28ac-1a2c-49fa-9be3-de997da5edcf

identifier: P-Isobutylhydratropic Acid
classification: Chemical
grade: USP-NF
manufacturer: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000
supplier: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+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:

Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a

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:

Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5

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:

Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049

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-ballot based on FHIR 5.0.0. Generated 2024-12-04
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