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
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/a2cba634-a481-4b07-9bd4-62c7ada31e1b | Version: 1.0.0-ballot | |||
| Active as of 2023-12-01 | Computable Name: | |||
| Other Identifiers: CitricAcidSpecification, OID:2.16.840.1.113883.4.642.40.36.34.3 | ||||
Generated Narrative: PlanDefinition
Resource PlanDefinition "a2cba634-a481-4b07-9bd4-62c7ada31e1b"
Profile: Quality Specification
Specification Type: Raw Materials/Excipients/Intermediates/Reagents (PQ-CMC-FDA Temporary Codes#C133931)
url: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/a2cba634-a481-4b07-9bd4-62c7ada31e1b
identifier: CitricAcidSpecification, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.3
version: 1.0.0-ballot
title: Citric acid specification Example
type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C48660 "Not Applicable")
status: active
subject: urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a
date: 2023-12-01
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)
goal
id
9bc2bfdf-c9b1-440a-bafe-89f2674341d4description: White Solid ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] White solid (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
59e2c94a-d383-4776-9b00-3b97b0741c9adescription: IR spectrum conforms to reference standard ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] IR spectrum conforms to reference standard (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
a2ed2d13-e96a-4d7b-b825-c69afd334cf7description: pH 3.4-4.3 ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] 3.4-4.3 pH
goal
id
e046aab8-b10f-4e13-89e6-bfa869a90b38description: residue <= 0.21% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] 0.21 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
action
id
fdf5e37f-ae97-48c1-9809-33aebff37199Test Order | Stage Sequence Order: 1
prefix: Single Stage
title: Appearance
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Organoleptic (Hierarchical Test Category Codes#TC6), Description/Appearance (Hierarchical Test Category Codes#SUBC20)
Documentations
Type Label documentation EX-TEST-101 goalId: 9bc2bfdf-c9b1-440a-bafe-89f2674341d4
action
id
f6da4e9e-4954-4fd1-a78a-b297fea64a6fTest Order | Stage Sequence Order: 2
prefix: Single Stage
title: Identification
code: FTIR (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Identification (Hierarchical Test Category Codes#TC7)
Documentations
Type Label documentation EX-TEST-102 goalId: 59e2c94a-d383-4776-9b00-3b97b0741c9a
action
id
a5beeff6-dcc1-4b42-8ea1-76dea4b0da1dTest Order | Stage Sequence Order: 3
prefix: Single Stage
title: pH
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: pH (Hierarchical Test Category Codes#TC23)
Documentations
Type Label documentation EX-TEST-103 goalId: a2ed2d13-e96a-4d7b-b825-c69afd334cf7
action
id
aad4c3ce-985d-45ab-9d00-c2c01ca3813fTest Order | Stage Sequence Order: 4
prefix: Single Stage
title: Residue on Ignition
code: Visual (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Residue on Ignition (Hierarchical Test Category Codes#TC38)
Documentations
Type Label documentation USP <281> goalId: e046aab8-b10f-4e13-89e6-bfa869a90b38
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 2024-04-08
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