Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
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
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/ab241f8c-d21e-4382-a70a-52190dbdf07e | Version: 1.1.6 | |||
| 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 ab241f8c-d21e-4382-a70a-52190dbdf07e
Specification Status: Not Applicable
url: PlanDefinition Raw Material (Carrageenan) Specification Example
identifier: RawCitricacid, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.5
version: 1.1.6
title: Raw Material (Carrageenan) Specification Example
type: Workflow Definition
status: Active
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
goal
id
e512320e-0ffb-47d9-922a-5415aaa4cb30description: Viscous upon cooling
addresses: Release, Stability
Targets
Detail[x] Viscous upon cooling
goal
id
2c6e465b-4dec-4a09-9dc5-58c480009d27description: Kappa, iota or lambda
addresses: Release, Stability
Targets
Detail[x] Kappa, iota or Lambda
goal
id
c233a5f7-37e2-4b2b-9f04-cf1b25534865description: Blue, stringy precipitate forms
addresses: Release, Stability
Targets
Detail[x] Blue stringy precipitate forms
goal
id
c759888d-1eac-4a12-aa9b-403f395f2c18description: FTIR matches standard
addresses: Release, Stability
Targets
Detail[x] FTIR matches standard
goal
id
66d4035c-633a-49b1-b974-e3171911f44adescription: max 200 cfu/g
addresses: Release, Stability
Targets
Detail[x] <=200 colony forming unit (Details: UCUM code[CFU] = '[CFU]')
goal
id
95bf9d43-f337-4905-9c50-788b69d00843description: Negative
addresses: Release, Stability
Targets
Detail[x] Negative
goal
id
4e475e2c-c235-4433-b1e4-201a17e45796description: Negative
addresses: Release, Stability
Targets
Detail[x] Negative
goal
id
af4ec6c3-4590-43f7-92e0-c8dae0e76e1fdescription: As Reported
addresses: Release, Stability
Targets
Detail[x] As Reported
goal
id
b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73description: As Reported
addresses: Release, Stability
Targets
Detail[x] As Reported
goal
id
464f3063-0a4b-4408-9f4a-d6c0b8170097description: <= 3 ppm
addresses: Release, Stability
Targets
Detail[x] <=3 part per million (Details: UCUM code[ppm] = '[ppm]')
goal
id
03fbc16c-d4d4-40ac-8689-448bda831dacdescription: <= 10 ppm
addresses: Release, Stability
Targets
Detail[x] <=10 part per million (Details: UCUM code[ppm] = '[ppm]')
goal
id
28aba010-126e-4c47-8611-367cdacdd87edescription: As Reported
addresses: Release, Stability
Targets
Detail[x] As Reported
goal
id
4b3aa353-3bc7-463f-b4c2-defd041da2c7description: <= 2.0%
addresses: Release, Stability
Targets
Detail[x] <=2 percent (Details: UCUM code% = '%')
goal
id
8125f603-96e7-4f3e-8b13-c15c5870e6e6description: <30ml H2O @ 25C
addresses: Release, Stability
target
detail: <=30 milliliter (Details: UCUM codemL = 'mL')
target
detail: <=25 degree Celsius (Details: UCUM codeCel = 'Cel')
action
id
428fa917-a7d3-4515-9b48-c9366acd673aprefix: Single Stage
title: Identification
code: Visual
reason: Identification
Documentations
Type Label Documentation EX-TEST-001 Actions
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-c049230091eaprefix: Single Stage
title: Microbial Limits
code: Visual
reason: Microbial Limits
Documentations
Type Label Documentation EX-TEST-002 Actions
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-4b47-8ec7-90ff44f7388cprefix: Single Stage
title: Elemental Impurities
code: UV
reason: Impurity, Elemental Impurity
Documentations
Type Label Documentation EX-TEST-003 Actions
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-ec3dd172c09fprefix: Single Stage
title: Residual Solvents
code: Visual
reason: Impurity, Residual Solvent
Documentations
Type Label Documentation EX-TEST-004 goalId: 28aba010-126e-4c47-8611-367cdacdd87e
action
id
25a64081-a0c2-4d72-8a48-538f81fcc35fprefix: Single Stage
title: Impurity: Insoluble Matter
code: Visual
reason: Impurity
Documentations
Type Label Documentation EX-TEST-005 goalId: 4b3aa353-3bc7-463f-b4c2-defd041da2c7
action
id
055a79d2-3f6b-49ec-a129-6feac5c33812prefix: Single Stage
title: Solubility in H2O
code: Visual
reason: Solubility
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#1.1.6 based on FHIR 5.0.0. Generated 2024-09-22
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