A quality specification is for a drug substance - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v1.1.6

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon 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 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

PlanDefinition: A quality specification is for a drug substance

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93				Version: 1.1.6
Active as of 2022-12-08				Computable Name:
Other Identifiers: ExampleSpecification2, OID:2.16.840.1.113883.4.642.40.36.34.6

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.

url: PlanDefinition Quality Specification for an API

identifier: ExampleSpecification2, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.6

version: 1.1.6

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

publisher: HL7 International / Biomedical Research and Regulation

contact: HL7 International / Biomedical Research and Regulation: http://www.hl7.org/Special/committees/rcrim,brr@lists.HL7.org

jurisdiction: United States of America

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

IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.1.6 based on FHIR 5.0.0. Generated 2024-09-22
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