Carrageenan specification Example - 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

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

PlanDefinition: Carrageenan specification Example

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/ab241f8c-d21e-4382-a70a-52190dbdf07e				Version: 1.0.0-ballot
Active as of 2023-11-28				Computable Name:
Other Identifiers: RawCitricacid, OID:2.16.840.1.113883.4.642.40.36.34.5

Generated Narrative: PlanDefinition

Resource PlanDefinition "ab241f8c-d21e-4382-a70a-52190dbdf07e"

Profile: Quality Specification

Specification Type: Raw Materials/Excipients/Intermediates/Reagents (PQ-CMC-FDA Temporary Codes#C133931)

url: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/ab241f8c-d21e-4382-a70a-52190dbdf07e

identifier: RawCitricacid, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.5

version: 1.0.0-ballot

title: Raw Material (Carrageenan) Specification Example

type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C48660 "Not Applicable")

status: active

subject: urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703

date: 2023-11-28

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 (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#US)

goal
id
e512320e-0ffb-47d9-922a-5415aaa4cb30
description: Viscous upon cooling ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Viscous upon cooling (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
2c6e465b-4dec-4a09-9dc5-58c480009d27
description: Kappa, iota or lambda ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Kappa, iota or Lambda (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
c233a5f7-37e2-4b2b-9f04-cf1b25534865
description: Blue, stringy precipitate forms ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Blue stringy precipitate forms (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
c759888d-1eac-4a12-aa9b-403f395f2c18
description: FTIR matches standard ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* FTIR matches standard (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
66d4035c-633a-49b1-b974-e3171911f44a
description: max 200 cfu/g ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 200 colony forming units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')

goal
id
95bf9d43-f337-4905-9c50-788b69d00843
description: Negative ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Negative (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
4e475e2c-c235-4433-b1e4-201a17e45796
description: Negative ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Negative (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
af4ec6c3-4590-43f7-92e0-c8dae0e76e1f
description: As Reported ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* As Reported (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73
description: As Reported ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* As Reported (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
464f3063-0a4b-4408-9f4a-d6c0b8170097
description: <= 3 ppm ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 3 parts per million (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48523 = '[ppm]')

goal
id
03fbc16c-d4d4-40ac-8689-448bda831dac
description: <= 10 ppm ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 10 parts per million (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48523 = '[ppm]')

goal
id
28aba010-126e-4c47-8611-367cdacdd87e
description: As Reported ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* As Reported (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
4b3aa353-3bc7-463f-b4c2-defd041da2c7
description: <= 2.0% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 2 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
8125f603-96e7-4f3e-8b13-c15c5870e6e6
description: <30ml H2O @ 25C ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
target
detail: 30 mL (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28254 = 'mL')
target
detail: 25 degree Celsius (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C42559 = 'Cel')

action
id
428fa917-a7d3-4515-9b48-c9366acd673a
Test Order | Stage Sequence Order: 1
prefix: Single Stage
title: Identification
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Identification (Hierarchical Test Category Codes#TC7)
Documentations
- Type Label
* documentation EX-TEST-001
Actions
- Extension Title GoalId
* Identification A e512320e-0ffb-47d9-922a-5415aaa4cb30
* Identification B 2c6e465b-4dec-4a09-9dc5-58c480009d27
* Identification C c233a5f7-37e2-4b2b-9f04-cf1b25534865
* Identification D c759888d-1eac-4a12-aa9b-403f395f2c18

action
id
f7cbb73f-4220-4987-b498-c049230091ea
Test Order | Stage Sequence Order: 2
prefix: Single Stage
title: Microbial Limits
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Microbial Limits (Hierarchical Test Category Codes#TC13)
Documentations
- Type Label
* documentation EX-TEST-002
Actions
- Extension Title GoalId
* Total Bacterial Count 66d4035c-633a-49b1-b974-e3171911f44a
* Salmonella 95bf9d43-f337-4905-9c50-788b69d00843
* Escherichia Coli 4e475e2c-c235-4433-b1e4-201a17e45796

action
id
f5f8221c-f9ec-4b47-8ec7-90ff44f7388c
Test Order | Stage Sequence Order: 3
prefix: Single Stage
title: Elemental Impurities
code: UV (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Impurity (Hierarchical Test Category Codes#TC53), elemental impurity (Hierarchical Test Category Codes#SUBC98)
Documentations
- Type Label
* documentation EX-TEST-003
Actions
- Extension Title GoalId
* Cadmium (Cd) af4ec6c3-4590-43f7-92e0-c8dae0e76e1f
* Mercury (Hg) b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73
* Arsenic (As) 464f3063-0a4b-4408-9f4a-d6c0b8170097
* Lead (Pb) 03fbc16c-d4d4-40ac-8689-448bda831dac

action
id
37b44e91-529a-4d87-843b-ec3dd172c09f
Test Order | Stage Sequence Order: 4
prefix: Single Stage
title: Residual Solvents
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Impurity (Hierarchical Test Category Codes#TC53), residual solvent (Hierarchical Test Category Codes#SUBC101)
Documentations
- Type Label
* documentation EX-TEST-004
goalId: 28aba010-126e-4c47-8611-367cdacdd87e

action
id
25a64081-a0c2-4d72-8a48-538f81fcc35f
Test Order | Stage Sequence Order: 5
prefix: Single Stage
title: Impurity: Insoluble Matter
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Impurity (Hierarchical Test Category Codes#TC53)
Documentations
- Type Label
* documentation EX-TEST-005
goalId: 4b3aa353-3bc7-463f-b4c2-defd041da2c7

action
id
055a79d2-3f6b-49ec-a129-6feac5c33812
Test Order | Stage Sequence Order: 6
prefix: Single Stage
title: Solubility in H2O
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Solubility (Hierarchical Test Category Codes#TC24)
Documentations
- Type Label
* documentation EX-TEST-006
goalId: 8125f603-96e7-4f3e-8b13-c15c5870e6e6

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 2024-04-08
Links: Table of Contents | QA Report | Version History | | Propose a change