Cochineal specification Example - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v1.1.6

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon 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 1.1.6 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

PlanDefinition: Cochineal specification Example

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e				Version: 1.1.6
Active as of 2023-12-01				Computable Name:
Other Identifiers: CochinealSpecification, OID:2.16.840.1.113883.4.642.40.36.34.1

Generated Narrative: PlanDefinition 37bf5cc0-33bf-478b-b84e-ccb35143ef6e

Specification Status: Not Applicable

url: PlanDefinition Cochineal specification Example

identifier: CochinealSpecification, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.1

version: 1.1.6

title: Cochineal specification Example

type: Workflow Definition

status: Active

subject: Bundle: identifier = UUID:813b4312-8b6d-42cc-9b8c-8bb6463388cc; type = document; timestamp = 2024-01-01 19:42:35+0000

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

goal
id
e900181a-876c-4ed6-ac96-d5a73c3d6767
description: White Solid
addresses: Release, Stability
Targets
- Detail[x]
* White solid

goal
id
21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c
description: IR spectrum conforms to reference standard
addresses: Release, Stability
Targets
- Detail[x]
* IR spectrum conforms to reference standard

goal
id
1f476689-f440-4a77-9e9c-0615af3571eb
description: pH 3.4-4.3
addresses: Release, Stability
Targets
- ModifierExtension
*

goal
id
9c0d2619-4505-4e6b-a801-bc30f84bc3e2
description: residue <= 0.21%
addresses: Release, Stability
Targets
- Detail[x]
* <=0.21 percent (Details: UCUM code% = '%')

goal
id
fc230a97-fd1a-4017-8603-822c5430a217
description: Formaldehyde NMT 1.5%
addresses: Release, Stability
Targets
- Detail[x]
* <=1.5 percent (Details: UCUM code% = '%')

goal
id
8d6688e0-7412-4d64-afe8-b73d8aec596e
description: Impurity C NMT 2%
addresses: Release, Stability
Targets
- Detail[x]
* <=2 percent (Details: UCUM code% = '%')

goal
id
f8e8343d-a37d-4b91-916b-f58d6947dc9c
description: 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-af76-326e07d1df9a
description: Total Impurities
addresses: Release, Stability
Targets
- Detail[x]
* <=0.7 percent (Details: UCUM code% = '%')

goal
id
cfdd469d-020b-4047-946f-f513d58f007f
description: Total Unidentified Impurities NMT 0.3%
addresses: Release, Stability
Targets
- Detail[x]
* <=0.3 percent (Details: UCUM code% = '%')

goal
id
c5eea380-416f-4d19-a21e-c021f3c7c543
description: 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-8bc1-6b0a6dca9d0c
description: 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-e588c51e032c
description: 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

IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.1.6 based on FHIR 5.0.0. Generated 2024-09-22
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