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 1.1.6 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
Document Content
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Resource Composition:
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identifier: ExampleSpecification2
status: Final
type: Substance Specification
date: 2023-12-15 22:36:51+0000
title: Quality Specification for an API
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Resource PlanDefinition:
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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
date: 2022-12-08
approvalDate: 2022-12-08
goal
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b304ed45-5295-4082-9827-f20e1ff0d1d3description: Negative
addresses: Release, Stability
Targets
Detail[x] Negative goal
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addresses: Release, Stability
Targets
Detail[x] Negative goal
id
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addresses: Release, Stability
Targets
Detail[x] Negative goal
id
c0ed4a79-8f40-4d26-8845-4cea166fb627description: 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-5ae5e4c531c1description: 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-ddc3dfb35c27title: 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
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Resource SubstanceDefinition:
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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
Codes
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Resource Organization:
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identifier: DUNS/143265222
name: Wunderwerke
Contacts
Address Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
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Resource Organization:
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identifier: DUNS/143265222, FEI/6981397
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Contacts
Address 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