7cdbb042-9275-4599-a1fe-08877846bf94 - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v1.0.0-ballot

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot 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 1.0.0-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

Example Bundle: 7cdbb042-9275-4599-a1fe-08877846bf94

Generated Narrative: Composition

Resource Composition "4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"

Profile: eCTD Specification Composition

identifier: CochinealSpecificationComposition

status: FINAL

type: Quality Specification (Code System PQCMC Comp Section Types#SP4151)

date: 2024-01-01 19:42:35+0000

author: See on this page: urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a

title: Cochineal specification Composition Example

32P40

See on this page: urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e

Additional Document Content

2. urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e (PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e)

Generated Narrative: PlanDefinition
Resource PlanDefinition "37bf5cc0-33bf-478b-b84e-ccb35143ef6e"
Profile: Quality Specification
Specification Type: Raw Materials/Excipients/Intermediates/Reagents (PQ-CMC-FDA Temporary Codes#C133931)
identifier: CochinealSpecification
version: 1.0
title: Cochineal specification Example
type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C48660 "Not Applicable")
status: ACTIVE
subject: See on this page: urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf
date: 2023-12-01
goal
id
e900181a-876c-4ed6-ac96-d5a73c3d6767
description: 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
21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c
description: 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
1f476689-f440-4a77-9e9c-0615af3571eb
description: 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
9c0d2619-4505-4e6b-a801-bc30f84bc3e2
description: residue <= 0.21% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.21 % (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
goal
id
fc230a97-fd1a-4017-8603-822c5430a217
description: Formaldehyde NMT 1.5% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 1.5 % (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
goal
id
8d6688e0-7412-4d64-afe8-b73d8aec596e
description: Impurity C NMT 2% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 2 % (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
goal
id
f8e8343d-a37d-4b91-916b-f58d6947dc9c
description: Unspecified Impurity NMT 0.10 % w/w ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.1 %{WeightToWeight} (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')
goal
id
be7abaa1-0769-4560-af76-326e07d1df9a
description: Total Impurities ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.7 % (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
goal
id
cfdd469d-020b-4047-946f-f513d58f007f
description: Total Unidentified Impurities NMT 0.3% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.3 % (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
goal
id
c5eea380-416f-4d19-a21e-c021f3c7c543
description: RRT 2.2 NMT 0.10% w/w ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.1 %{WeightToWeight} (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')
goal
id
41e19fa2-f568-443e-8bc1-6b0a6dca9d0c
description: RRT 2.4 NMT 0.10% w/w ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.1 %{WeightToWeight} (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')
goal
id
e493cb3d-45b6-4463-b9b6-e588c51e032c
description: RRT 3.41 NMT 0.10% w/w ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.2 %{WeightToWeight} (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48528 = '%{WeightToWeight}')
action
Test Order | Stage Sequence Order: 1
linkId: b9359ce8-73f3-45c5-9674-98d850053aa2
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: e900181a-876c-4ed6-ac96-d5a73c3d6767
action
Test Order | Stage Sequence Order: 2
linkId: 443ed163-7a7b-4d48-9462-be5532158411
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: 21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c
action
Test Order | Stage Sequence Order: 3
linkId: 058193ee-dd86-4c63-9f47-7b0608abbca4
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: 1f476689-f440-4a77-9e9c-0615af3571eb
action
Test Order | Stage Sequence Order: 4
linkId: 940c8db4-9ed1-416e-84ec-9f9e143be8ab
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: 9c0d2619-4505-4e6b-a801-bc30f84bc3e2
action
Test Order | Stage Sequence Order: 5
linkId: 9fca0a37-6d10-4273-a966-c026ab6eb07d
prefix: Single Stage
title: Impurities
code: FTIR (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Impurity (Hierarchical Test Category Codes#TC53)
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
Test Order | Stage Sequence Order: 5.1

3. urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf (SubstanceDefinition/278736ef-2ddf-49e4-895c-3a9f34db36cf)

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "278736ef-2ddf-49e4-895c-3a9f34db36cf"
Profile: Excipient Drug Substance
identifier: Cochineal
classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)
grade: Company Standard (PQ-CMC-FDA Temporary Codes#C134009)
Codes
- Code
* TZ8Z31B35M (Unique Ingredient Identifier (UNII)#TZ8Z31B35M)
Names
- Name Type Preferred
* Cochineal GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355) true
SourceMaterials
- Type Genus Species CountryOfOrigin
* Chemical (PQ-CMC-FDA Temporary Codes#C48807) Dactylopius () cochineal () Turkey (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#TUR)

4. urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a (Organization/4f3e9af1-306b-4fad-bf04-7881400b266a)

Generated Narrative: Organization
Resource Organization "4f3e9af1-306b-4fad-bf04-7881400b266a"
Profile: Sponsor Organization
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#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