A quality specification is for a drug product - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v1.0.0-ballot

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: A quality specification is for a drug product

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7				Version: 1.0.0-ballot
Active as of 2022-12-08				Computable Name:
Other Identifiers: ExampleSpecification, OID:2.16.840.1.113883.4.642.40.36.34.4

Generated Narrative: PlanDefinition

Resource PlanDefinition "aa514363-d43f-4052-b44e-b67aa4d6dee7"

Profile: Quality Specification

Specification Type: Drug Product (PQ-CMC-FDA Temporary Codes#C134021)

url: http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7

identifier: ExampleSpecification, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.36.34.4

version: 1.0.0-ballot

title: Quality Specification for OXAZEPAM

type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C134011 "Not Approved")

status: active

subject: urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9

date: 2022-12-08

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
32649771-1290-4386-9cf7-7a72274f22b4
description: Average of 10 between 2-3 pH ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 2-3 pH

goal
id
59a4ca76-858e-4d58-8e5f-88e75f51ec33
description: Maxima only at the same wavelengths compared to reference standard ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Conforms (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
c40aa176-e6aa-4fe4-869d-6550ee992903
description: <= 0.5 % ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.5 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
b122987d-586c-481b-951c-6202e660158d
description: Color of solution is clear ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Conforms (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
929747ad-e83a-46f0-bbbc-133ee951e819
description: <= 0.05 % ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.05 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
8d7c85c2-7a4b-432e-ac94-226f296e4fca
description: No Particulate Matter detected ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* pass (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
de4f962a-d486-486d-8d84-f2d1635646b4
description: <= 0.014 % ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.014 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
b46dce64-a009-46cd-ab95-21d1d5b4df77
description: <= 0.04 % ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.04 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
5566f501-37e1-49fb-8783-b20c074ec0c3
description: <= 0.001 % ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.001 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
db19e3ab-e28b-4477-8bd7-2409093ed5a3
description: Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* pass (PQ-CMC-FDA Temporary Codes#C48793 "EQ")

goal
id
82370588-7aae-4556-9262-a7f50dbd01aa
description: Ethanol < 0.2% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Measure Detail[x]
* Ethanol () 0.2 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2
description: Ethyl Ether < 0.1% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Measure Detail[x]
* Ethyl Ether () 0.1 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
28ad4d5b-d975-4f6e-9792-b3d9cc7ce279
description: 1—propanol < 0.15% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Measure Detail[x]
* 1—propanol () 0.15 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
33fa051c-6b3c-4e4d-bd4e-09d39fc253b3
description: Total < 0.5% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Measure Detail[x]
* Total Residual Solvents () 0.5 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
9100e938-42ff-4004-8473-ed5090d66f3a
description: 99.5 - 100.5 % ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 99.5-100.5 percent

goal
id
af260128-f105-4692-ba40-49f21f12ad46
description: n=6 ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Detail[x]
* 6

goal
id
31d9dcac-bf72-420b-a415-c924155a83f4
description: Each unit is NLT Q + 5% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Detail[x]
* 85 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
47c0d685-0b23-4637-9af8-a554e4fad7ec
description: n=6 ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Detail[x]
* 6

goal
id
14d3dee8-e024-4367-b0a2-a2a809303ee0
description: Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q – 15% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
target
measure: Average of 12 units ()
detail: 80 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
target
measure: unit ()
detail: 65 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal
id
15309a78-92a9-4cf9-aee1-452d6d2f7a91
description: Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15%, no unit is less than Q – 25% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
target
measure: Average of 24 units ()
detail: 80 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
target
measure: units less than Q – 15% ()
detail: 2 amb a 1 units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C92953 = '[Amb'a'1'U]')
target
measure: units less than Q – 25% ()
detail: 0 amb a 1 units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C92953 = '[Amb'a'1'U]')

goal
id
666ace1e-bd29-4263-9ae2-2391106326bb
description: n=12 ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Detail[x]
* 12

action
id
2047a6b6-e3fc-4071-8989-526297579091
Test Order | Stage Sequence Order: 1.1
prefix: Single Stage
title: Spectrophotometry Identification
description: Alternate
code: Spectrophotometry (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Identification (Hierarchical Test Category Codes#TC7)
Documentations
- Type Label
* documentation USP <197>
goalId: 32649771-1290-4386-9cf7-7a72274f22b4
RelatedActions
- TargetId Relationship
* 84d64dd8-b799-418a-a713-a854c4d3c2b9 concurrent
selectionBehavior: exactly-one

action
id
84d64dd8-b799-418a-a713-a854c4d3c2b9
Test Order | Stage Sequence Order: 1.2
linkId: 2047a6b6-e3fc-4071-8989-526297579091
prefix: Single Stage
title: Identity - Ferric Chloride
description: Alternate
code: HPLC (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Identification (Hierarchical Test Category Codes#TC7)
Documentations
- Type Label
* documentation EX-TEST-01
goalId: 59a4ca76-858e-4d58-8e5f-88e75f51ec33
RelatedActions
- TargetId Relationship
* 2047a6b6-e3fc-4071-8989-526297579091 concurrent
selectionBehavior: exactly-one

action
id
838e66ce-f4b0-47a5-8ea0-aa7882a84303
Test Order | Stage Sequence Order: 2
prefix: Single Stage
title: Loss on Drying
code: Visual (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Loss on Drying (Hierarchical Test Category Codes#TC12)
Documentations
- Type Label
* documentation USP <731>
goalId: c40aa176-e6aa-4fe4-869d-6550ee992903

action
id
3510686b-fb93-4980-a41c-0a3754be7f37
Test Order | Stage Sequence Order: 3
prefix: Single Stage
title: Readily Carbonizable Sub
code: Visual (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Organoleptic (Hierarchical Test Category Codes#TC6), Color of solution (Hierarchical Test Category Codes#SUBC22)
Documentations
- Type Label
* documentation USP <271>
goalId: b122987d-586c-481b-951c-6202e660158d

action
id
b2e18cc4-f494-4ef0-be34-810d8d4b439b
Test Order | Stage Sequence Order: 4
prefix: Single Stage
title: Residue on ignition (Ash)
code: Visual (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Residue on Ignition (Hierarchical Test Category Codes#TC38)
Documentations
- Type Label
* documentation USP <281>
goalId: 929747ad-e83a-46f0-bbbc-133ee951e819

action
id
d315a1c3-dd93-498d-8ae3-dc0d4b3bec75
Test Order | Stage Sequence Order: 5
prefix: Single Stage
title: Substances insoluble in sodium carbonate TS
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Foreign and Particulate Matter (Hierarchical Test Category Codes#TC11)
Documentations
- Type Label
* documentation EX-TEST-02
goalId: 8d7c85c2-7a4b-432e-ac94-226f296e4fca

action
id
6ec15bbc-a78a-4351-9ad8-fcf97e839ab9
Test Order | Stage Sequence Order: 6
prefix: Single Stage
title: Impurities - Chloride (Cl)
code: FTIR (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Impurity (Hierarchical Test Category Codes#TC53), Specified identified impurity (Hierarchical Test Category Codes#SUBC92)
Documentations
- Type Label
* documentation USP <221>
goalId: de4f962a-d486-486d-8d84-f2d1635646b4

action
id
fa31b425-896c-4b25-b693-ccdd14e0c8ee
Test Order | Stage Sequence Order: 7
prefix: Single Stage
title: Impurities - Sulfate (SO4)
code: FTIR (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Impurity (Hierarchical Test Category Codes#TC53), Specified identified impurity (Hierarchical Test Category Codes#SUBC92)
Documentations
- Type Label
* documentation USP <221>
goalId: b46dce64-a009-46cd-ab95-21d1d5b4df77

action
id
cef5aa1a-8770-4f78-9bc3-da9f18b77e5c
Test Order | Stage Sequence Order: 8
prefix: Single Stage
title: Elemental Impurities - Limits
code: UV (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Impurity (Hierarchical Test Category Codes#TC53), elemental impurity (Hierarchical Test Category Codes#SUBC98)
Documentations
- Type Label
* documentation USP <231>
goalId: 5566f501-37e1-49fb-8783-b20c074ec0c3

action
id
d5871ee2-8b06-414c-91b4-4b30f5881c8a
Test Order | Stage Sequence Order: 9
prefix: Single Stage
title: Limit of Free Salicylic Acid
code: Titration (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Impurity (Hierarchical Test Category Codes#TC53), Impurities/Degradation Products/Related Substances (Hierarchical Test Category Codes#SUBC100)
Documentations
- Type Label
* documentation EX-TEST-03
goalId: db19e3ab-e28b-4477-8bd7-2409093ed5a3

action
id
e192fc72-c4b1-419f-8098-6f65037a3962
Test Order | Stage Sequence Order: 10
prefix: Single Stage
title: Organic Volatile Impurities
code: Visual (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Impurity (Hierarchical Test Category Codes#TC53), residual solvent (Hierarchical Test Category Codes#SUBC101)
Documentations
- Type Label
* documentation USP <467>
goalId: 82370588-7aae-4556-9262-a7f50dbd01aa, cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2, 28ad4d5b-d975-4f6e-9792-b3d9cc7ce279, 33fa051c-6b3c-4e4d-bd4e-09d39fc253b3

action
id
b7e88ea0-3c61-49db-86ec-8d01f8b7667b
Test Order | Stage Sequence Order: 11
prefix: Single Stage
title: Assay Dry Basis
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Assay (Hierarchical Test Category Codes#TC1), active ingredient (Hierarchical Test Category Codes#SUBC2)
Documentations
- Type Label
* documentation EX-TEST-04
goalId: 9100e938-42ff-4004-8473-ed5090d66f3a

action
id
6d1ba5a8-6590-496a-ad6b-ca68cfda2878
Test Order | Stage Sequence Order: 12
title: Dissolution - 30 minute
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Dissolution (Hierarchical Test Category Codes#TC9)
Documentations
- Type Label
* documentation EX-TEST-05
Actions
- Extension LinkId Prefix GoalId
* 6d1ba5a8-6590-496a-ad6b-ca68cfda2878 Stage 1 af260128-f105-4692-ba40-49f21f12ad46, 31d9dcac-bf72-420b-a415-c924155a83f4
* 6d1ba5a8-6590-496a-ad6b-ca68cfda2878 Stage 2 47c0d685-0b23-4637-9af8-a554e4fad7ec, 14d3dee8-e024-4367-b0a2-a2a809303ee0
* 6d1ba5a8-6590-496a-ad6b-ca68cfda2878 Stage 3 15309a78-92a9-4cf9-aee1-452d6d2f7a91, 666ace1e-bd29-4263-9ae2-2391106326bb