Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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

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Resource Composition:

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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

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Resource PlanDefinition:

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Version: 1.0

ExampleSpecification2

Title: Quality Specification for an API
Type:

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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:
Microbiological Examination of Nonsterile Products:
Then:
Stage 1 Staphylococcus aureus:
Stage 2 Pseudomonas aeruginosa:
Stage 3 Bacillus subtilis:
Stage 4 Total Aerobic Microbial Count (TAMC):
Stage 5 Total Yeasts and Molds Count (TYMC):

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Resource SubstanceDefinition:

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identifier: P-Isobutylhydratropic Acid

classification: Chemical

grade: USP-NF

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supplier: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000

Codes

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Names

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identifier: DUNS/143265222

name: Wunderwerke

Contacts

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

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Contacts

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*Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA

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Resource Organization:

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identifier: DUNS/173265332

name: Mega Chem Supply

Contacts

-Address
*Mega Chem Supply, 350 W Main Street, Rochester, NY, United States