Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
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 2.0.0-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
Document Content
Entry 1 - fullUrl = urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4
Resource Composition:
Generated Narrative: Composition 4bd1ed57-852b-42be-a9b0-355f8a2aa7d4
identifier: CochinealSpecificationComposition
status: Final
type: Control of Excipients
date: 2024-01-01 19:42:35+0000
title: Cochineal specification Composition Example
Entry 2 - fullUrl = urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e
Resource PlanDefinition:
Generated Narrative: PlanDefinition 37bf5cc0-33bf-478b-b84e-ccb35143ef6e
Specification Status: Not Applicable
identifier: CochinealSpecification
version: 1.0
title: Cochineal specification Example
type: Workflow Definition
status: Active
date: 2023-12-01
goal
id
e900181a-876c-4ed6-ac96-d5a73c3d6767description: White Solid
addresses: Release, Stability
Targets
Detail[x] White solid goal
id
21c69fab-2cb3-46dc-8c56-d1c64d5ddf5cdescription: IR spectrum conforms to reference standard
addresses: Release, Stability
Targets
Detail[x] IR spectrum conforms to reference standard goal
id
1f476689-f440-4a77-9e9c-0615af3571ebdescription: pH 3.4-4.3
addresses: Release, Stability
Targets
ModifierExtension goal
id
9c0d2619-4505-4e6b-a801-bc30f84bc3e2description: residue <= 0.21%
addresses: Release, Stability
Targets
Detail[x] <=0.21 percent (Details: UCUM code% = '%') goal
id
fc230a97-fd1a-4017-8603-822c5430a217description: Formaldehyde NMT 1.5%
addresses: Release, Stability
Targets
Detail[x] <=1.5 percent (Details: UCUM code% = '%') goal
id
8d6688e0-7412-4d64-afe8-b73d8aec596edescription: Impurity C NMT 2%
addresses: Release, Stability
Targets
Detail[x] <=2 percent (Details: UCUM code% = '%') goal
id
f8e8343d-a37d-4b91-916b-f58d6947dc9cdescription: Unspecified Impurity NMT 0.10 % w/w
addresses: Release, Stability
Targets
Detail[x] <=0.1 percent WeightToWeight (Details: UCUM code%{WeightToWeight} = '%{WeightToWeight}') goal
id
be7abaa1-0769-4560-af76-326e07d1df9adescription: Total Impurities
addresses: Release, Stability
Targets
Detail[x] <=0.7 percent (Details: UCUM code% = '%') goal
id
cfdd469d-020b-4047-946f-f513d58f007fdescription: Total Unidentified Impurities NMT 0.3%
addresses: Release, Stability
Targets
Detail[x] <=0.3 percent (Details: UCUM code% = '%') goal
id
c5eea380-416f-4d19-a21e-c021f3c7c543description: RRT 2.2 NMT 0.10% w/w
addresses: Release, Stability
Targets
Detail[x] <=0.1 percent WeightToWeight (Details: UCUM code%{WeightToWeight} = '%{WeightToWeight}') goal
id
41e19fa2-f568-443e-8bc1-6b0a6dca9d0cdescription: RRT 2.4 NMT 0.10% w/w
addresses: Release, Stability
Targets
Detail[x] <=0.1 percent WeightToWeight (Details: UCUM code%{WeightToWeight} = '%{WeightToWeight}') goal
id
e493cb3d-45b6-4463-b9b6-e588c51e032cdescription: RRT 3.41 NMT 0.10% w/w
addresses: Release, Stability
Targets
Detail[x] <=0.2 percent WeightToWeight (Details: UCUM code%{WeightToWeight} = '%{WeightToWeight}') action
linkId: b9359ce8-73f3-45c5-9674-98d850053aa2
prefix: Single Stage
title: Appearance
code: Visual
reason: Organoleptic, Description/Appearance
Documentations
Type Label Documentation EX-TEST-101 goalId: e900181a-876c-4ed6-ac96-d5a73c3d6767
action
linkId: 443ed163-7a7b-4d48-9462-be5532158411
prefix: Single Stage
title: Identification
code: FTIR
reason: Identification
Documentations
Type Label Documentation EX-TEST-102 goalId: 21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c
action
linkId: 058193ee-dd86-4c63-9f47-7b0608abbca4
prefix: Single Stage
title: pH
code: Visual
reason: pH
Documentations
Type Label Documentation EX-TEST-103 goalId: 1f476689-f440-4a77-9e9c-0615af3571eb
action
linkId: 940c8db4-9ed1-416e-84ec-9f9e143be8ab
prefix: Single Stage
title: Residue on Ignition
code: Visual
reason: Residue on Ignition
Documentations
Type Label Documentation USP <281> goalId: 9c0d2619-4505-4e6b-a801-bc30f84bc3e2
action
linkId: 9fca0a37-6d10-4273-a966-c026ab6eb07d
prefix: Single Stage
title: Impurities
code: FTIR
reason: Impurity
Documentations
Type Label Documentation EX-TEST-104 goalId: fc230a97-fd1a-4017-8603-822c5430a217, 8d6688e0-7412-4d64-afe8-b73d8aec596e, f8e8343d-a37d-4b91-916b-f58d6947dc9c, be7abaa1-0769-4560-af76-326e07d1df9a, cfdd469d-020b-4047-946f-f513d58f007f
action
title: Unidentified Impurities
Actions
Prefix Title GoalId RRT 2.2 c5eea380-416f-4d19-a21e-c021f3c7c543 RRT 2.4 41e19fa2-f568-443e-8bc1-6b0a6dca9d0c RRT 3.41 e493cb3d-45b6-4463-b9b6-e588c51e032c
Entry 3 - fullUrl = urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition 278736ef-2ddf-49e4-895c-3a9f34db36cf
identifier: Cochineal
classification: Chemical
grade: Company Standard
Codes
Code TZ8Z31B35M Names
Name Type Preferred Cochineal GSRS Preferred Term true SourceMaterials
Type Genus Species CountryOfOrigin Chemical Dactylopius cochineal Turkey
Entry 4 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a
Resource Organization:
Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a
identifier: DUNS/143265222
name: Wunderwerke
Contacts
Address Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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