Water 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: Water Specification Example

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/5819b223-d3d2-419f-b617-b3a9a3625b89				Version: 1.1.6
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 5819b223-d3d2-419f-b617-b3a9a3625b89

Specification Status: Not Applicable

url: PlanDefinition Water Specification Example

identifier: WaterSpecification, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.2

version: 1.1.6

title: Water 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
1779ee35-8725-4322-ae82-89ed499f6864
description: <=12 deg
addresses: Release
Targets
- Detail[x]
* <=12 degree (Details: UCUM codedeg = 'deg')

goal
id
2897e150-8465-48c7-9269-1cda86dc3075
description: Conforms to reference standard
addresses: Release
Targets
- Detail[x]
* Conforms to reference standard

goal
id
9c86ccba-a210-4ce5-9a23-b145d9f123c6
description: Odorless
addresses: Release
Targets
- Detail[x]
* Odorless

goal
id
de0f0d85-5617-4b07-98fc-9976b2dbf216
description: <= 395mg/L
addresses: Release
Targets
- Detail[x]
* <=395 milligram (Details: UCUM codemg = 'mg')

action
id
3668eb6f-797c-4325-8f41-160c951b4adc
prefix: Single Stage
title: Color degree
code: Colorimetry
reason: Organoleptic, Color of Solution
Documentations
- Type Label
* Documentation EX-TEST-201
goalId: 1779ee35-8725-4322-ae82-89ed499f6864

action
id
42cf5de4-2c64-48fc-a4d8-9e74066c36a3
prefix: Single Stage
title: Turbidity
code: Spectrophotometer
reason: Turbidity
Documentations
- Type Label
* Documentation EX-TEST-202
goalId: 2897e150-8465-48c7-9269-1cda86dc3075

action
id
c552eee7-4dca-4a01-b291-5044d5132cc9
prefix: Single Stage
title: Smell and taste
code: Smell
reason: Organoleptic, Odor
Documentations
- Type Label
* Documentation EX-TEST-203
goalId: 9c86ccba-a210-4ce5-9a23-b145d9f123c6

action
id
b33b402a-0dc7-4953-a7b8-aa2efeb8434f
prefix: Single Stage
title: Total hardness
code: Titration
reason: Hardness
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#1.1.6 based on FHIR 5.0.0. Generated 2024-09-22
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