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/5819b223-d3d2-419f-b617-b3a9a3625b89 | Version: 1.0.0-ballot | |||
| Active as of 2023-12-01 | Computable Name: | |||
| Other Identifiers: WaterSpecification, OID:2.16.840.1.113883.4.642.40.36.34.2 | ||||
Generated Narrative: PlanDefinition
Resource PlanDefinition "5819b223-d3d2-419f-b617-b3a9a3625b89"
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/5819b223-d3d2-419f-b617-b3a9a3625b89
identifier: WaterSpecification, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.2
version: 1.0.0-ballot
title: Water Specification Example
type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C48660 "Not Applicable")
status: active
subject: urn:uuid:d3a11b25-e160-4688-b807-6383364096fd
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
1779ee35-8725-4322-ae82-89ed499f6864description: <=12 deg ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
Detail[x] 12 degrees of rotation (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68667 = 'deg')
goal
id
2897e150-8465-48c7-9269-1cda86dc3075description: Conforms to reference standard ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
Detail[x] Conforms to reference standard (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
9c86ccba-a210-4ce5-9a23-b145d9f123c6description: Odorless ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
Detail[x] Odorless (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
de0f0d85-5617-4b07-98fc-9976b2dbf216description: <= 395mg/L ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
Detail[x] 395 milligram (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
action
id
3668eb6f-797c-4325-8f41-160c951b4adcTest Order | Stage Sequence Order: 1
prefix: Single Stage
title: Color degree
code: Colorimetry (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Organoleptic (Hierarchical Test Category Codes#TC6), Color of solution (Hierarchical Test Category Codes#SUBC22)
Documentations
Type Label documentation EX-TEST-201 goalId: 1779ee35-8725-4322-ae82-89ed499f6864
action
id
42cf5de4-2c64-48fc-a4d8-9e74066c36a3Test Order | Stage Sequence Order: 2
prefix: Single Stage
title: Turbidity
code: Spectrophotometer (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Turbidity (Hierarchical Test Category Codes#TC51)
Documentations
Type Label documentation EX-TEST-202 goalId: 2897e150-8465-48c7-9269-1cda86dc3075
action
id
c552eee7-4dca-4a01-b291-5044d5132cc9Test Order | Stage Sequence Order: 3
prefix: Single Stage
title: Smell and taste
code: Smell (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Organoleptic (Hierarchical Test Category Codes#TC6), Odor (Hierarchical Test Category Codes#SUBC21)
Documentations
Type Label documentation EX-TEST-203 goalId: 9c86ccba-a210-4ce5-9a23-b145d9f123c6
action
id
b33b402a-0dc7-4953-a7b8-aa2efeb8434fTest Order | Stage Sequence Order: 4
prefix: Single Stage
title: Total hardness
code: Titration (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Hardness (Hierarchical Test Category Codes#TC20)
Documentations
Type Label documentation EX-TEST-204 goalId: de0f0d85-5617-4b07-98fc-9976b2dbf216
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
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