Citric acid 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: Citric acid specification Example

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/a2cba634-a481-4b07-9bd4-62c7ada31e1b				Version: 1.1.6
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 a2cba634-a481-4b07-9bd4-62c7ada31e1b

Specification Status: Not Applicable

url: PlanDefinition Citric acid specification Example

identifier: CitricAcidSpecification, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.3

version: 1.1.6

title: Citric acid specification Example

type: Workflow Definition

status: Active

subject: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+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
9bc2bfdf-c9b1-440a-bafe-89f2674341d4
description: White Solid
addresses: Release, Stability
Targets
- Detail[x]
* White solid

goal
id
59e2c94a-d383-4776-9b00-3b97b0741c9a
description: IR spectrum conforms to reference standard
addresses: Release, Stability
Targets
- Detail[x]
* IR spectrum conforms to reference standard

goal
id
a2ed2d13-e96a-4d7b-b825-c69afd334cf7
description: pH 3.4-4.3
addresses: Release, Stability
Targets
- ModifierExtension
*

goal
id
e046aab8-b10f-4e13-89e6-bfa869a90b38
description: residue <= 0.21%
addresses: Release, Stability
Targets
- Detail[x]
* <=0.21 percent (Details: UCUM code% = '%')

action
id
fdf5e37f-ae97-48c1-9809-33aebff37199
prefix: Single Stage
title: Appearance
code: Visual
reason: Organoleptic, Description/Appearance
Documentations
- Type Label
* Documentation EX-TEST-101
goalId: 9bc2bfdf-c9b1-440a-bafe-89f2674341d4

action
id
f6da4e9e-4954-4fd1-a78a-b297fea64a6f
prefix: Single Stage
title: Identification
code: FTIR
reason: Identification
Documentations
- Type Label
* Documentation EX-TEST-102
goalId: 59e2c94a-d383-4776-9b00-3b97b0741c9a

action
id
a5beeff6-dcc1-4b42-8ea1-76dea4b0da1d
prefix: Single Stage
title: [pH]
code: Visual
reason: pH
Documentations
- Type Label
* Documentation EX-TEST-103
goalId: a2ed2d13-e96a-4d7b-b825-c69afd334cf7

action
id
aad4c3ce-985d-45ab-9d00-c2c01ca3813f
prefix: Single Stage
title: Residue on Ignition
code: Visual
reason: Residue on Ignition
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#1.1.6 based on FHIR 5.0.0. Generated 2024-09-22
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