Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
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 1.0.0-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
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93 | Version: 1.0.0-ballot | |||
| 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
Resource PlanDefinition "cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"
Profile: Quality Specification
Specification Type: Drug Substance (PQ-CMC-FDA Temporary Codes#C134022)
Additional Information: This API is is currently characterized through a standard battery of physicochemical characterzation tests.
url: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93
identifier: ExampleSpecification2, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.6
version: 1.0.0-ballot
title: Quality Specification for an API
type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C134010 "Tentatively Approved")
status: active
subject: urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf
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 (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#US)
approvalDate: 2022-12-08
goal
id
b304ed45-5295-4082-9827-f20e1ff0d1d3description: Negative ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] Negative (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
d4e38c52-30f6-4bb7-ab84-99439a7266cedescription: Negative ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] Negative (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
2abf1f19-e1b1-42e4-b943-79f5fa1642fedescription: Negative ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] Negative (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
c0ed4a79-8f40-4d26-8845-4cea166fb627description: NMT 10 colony-forming units ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] 10 colony forming units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')
goal
id
442983b5-bbc3-4534-9f1b-5ae5e4c531c1description: NMT 100 colony-forming units ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] 100 colony forming units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')
action
id
997a8ec6-eabf-41a3-b166-ddc3dfb35c27Test Order | Stage Sequence Order: 1
title: Microbiological Examination of Nonsterile Products
code: Visual (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Microbial Limits (Hierarchical Test Category Codes#TC13)
Documentations
Type Label documentation USP <61> Actions
Extension 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#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-04
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change