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
Document Content
Entry 1 - fullUrl = urn:uuid:d332acdf-4874-407b-9950-528f14c6bea2
Resource Composition:
Generated Narrative: Composition d332acdf-4874-407b-9950-528f14c6bea2
identifier: ExampleSpecification
status: Final
type: Product Specification
date: 2023-12-15 22:33:13+0000
title: Quality Specification for an example Drug Product
Entry 2 - fullUrl = urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7
Resource PlanDefinition:
Generated Narrative: PlanDefinition aa514363-d43f-4052-b44e-b67aa4d6dee7
Specification Status: Not Approved
identifier: ExampleSpecification
version: 1.0
title: Quality Specification for OXAZEPAM
type: Workflow Definition
status: Active
date: 2022-12-08
goal
id
32649771-1290-4386-9cf7-7a72274f22b4description: Average of 10 between 2-3 pH
addresses: Release, Stability
Targets
ModifierExtension goal
id
59a4ca76-858e-4d58-8e5f-88e75f51ec33description: Maxima only at the same wavelengths compared to reference standard
addresses: Release, Stability
Targets
Detail[x] Conforms goal
id
c40aa176-e6aa-4fe4-869d-6550ee992903description: <= 0.5 %
addresses: Release, Stability
Targets
Detail[x] <=0.5 percent (Details: UCUM code% = '%') goal
id
b122987d-586c-481b-951c-6202e660158ddescription: Color of solution is clear
addresses: Release, Stability
Targets
Detail[x] Conforms goal
id
929747ad-e83a-46f0-bbbc-133ee951e819description: <= 0.05 %
addresses: Release, Stability
Targets
Detail[x] <=0.05 percent (Details: UCUM code% = '%') goal
id
8d7c85c2-7a4b-432e-ac94-226f296e4fcadescription: No Particulate Matter detected
addresses: Release, Stability
Targets
Detail[x] pass goal
id
de4f962a-d486-486d-8d84-f2d1635646b4description: <= 0.014 %
addresses: Release, Stability
Targets
Detail[x] <=0.014 percent (Details: UCUM code% = '%') goal
id
b46dce64-a009-46cd-ab95-21d1d5b4df77description: <= 0.04 %
addresses: Release, Stability
Targets
Detail[x] <=0.04 percent (Details: UCUM code% = '%') goal
id
5566f501-37e1-49fb-8783-b20c074ec0c3description: <= 0.001 %
addresses: Release, Stability
Targets
Detail[x] <=0.001 percent (Details: UCUM code% = '%') goal
id
db19e3ab-e28b-4477-8bd7-2409093ed5a3description: Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution
addresses: Release, Stability
Targets
Detail[x] pass goal
id
82370588-7aae-4556-9262-a7f50dbd01aadescription: Ethanol < 0.2%
addresses: Release, Stability
Targets
Measure Detail[x] Ethanol <=0.2 percent (Details: UCUM code% = '%') goal
id
cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2description: Ethyl Ether < 0.1%
addresses: Release
Targets
Measure Detail[x] Ethyl Ether <=0.1 percent (Details: UCUM code% = '%') goal
id
28ad4d5b-d975-4f6e-9792-b3d9cc7ce279description: 1—propanol < 0.15%
addresses: Release
Targets
Measure Detail[x] 1—propanol <=0.15 percent (Details: UCUM code% = '%') goal
id
33fa051c-6b3c-4e4d-bd4e-09d39fc253b3description: Total < 0.5%
addresses: Release
Targets
Measure Detail[x] Total Residual Solvents <=0.5 percent (Details: UCUM code% = '%') goal
id
9100e938-42ff-4004-8473-ed5090d66f3adescription: 99.5 - 100.5 %
addresses: Release, Stability
Targets
ModifierExtension goal
id
af260128-f105-4692-ba40-49f21f12ad46description: n=6
addresses: Release
Targets
Detail[x] 6 goal
id
31d9dcac-bf72-420b-a415-c924155a83f4description: Each unit is NLT Q + 5%
addresses: Release
Targets
Detail[x] <=85 percent (Details: UCUM code% = '%') goal
id
47c0d685-0b23-4637-9af8-a554e4fad7ecdescription: n=6
addresses: Release
Targets
Detail[x] 6 goal
id
14d3dee8-e024-4367-b0a2-a2a809303ee0description: Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q – 15%
addresses: Release
target
measure: Average of 12 units
detail: <=80 percent (Details: UCUM code% = '%')
target
measure: unit
detail: <=65 percent (Details: UCUM code% = '%')
goal
id
15309a78-92a9-4cf9-aee1-452d6d2f7a91description: 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
target
measure: Average of 24 units
detail: <=80 percent (Details: UCUM code% = '%')
target
measure: units less than Q – 15%
detail: <=2 Amb a 1 units (Details: UCUM code[Amb'a'1'U] = '[Amb'a'1'U]')
target
measure: units less than Q – 25%
detail: <=0 Amb a 1 units (Details: UCUM code[Amb'a'1'U] = '[Amb'a'1'U]')
goal
id
666ace1e-bd29-4263-9ae2-2391106326bbdescription: n=12
addresses: Release
Targets
Detail[x] 12 action
id
2047a6b6-e3fc-4071-8989-526297579091prefix: Single Stage
title: Spectrophotometry Identification
description:
Alternate
code: Spectrophotometry
reason: Identification
Documentations
Type Label Documentation USP <197> goalId: 32649771-1290-4386-9cf7-7a72274f22b4
RelatedActions
TargetId Relationship 84d64dd8-b799-418a-a713-a854c4d3c2b9 Concurrent action
id
84d64dd8-b799-418a-a713-a854c4d3c2b9linkId: 2047a6b6-e3fc-4071-8989-526297579091
prefix: Single Stage
title: Identity - Ferric Chloride
description:
Alternate
code: HPLC
reason: Identification
Documentations
Type Label Documentation EX-TEST-01 goalId: 59a4ca76-858e-4d58-8e5f-88e75f51ec33
RelatedActions
TargetId Relationship 2047a6b6-e3fc-4071-8989-526297579091 Concurrent action
id
838e66ce-f4b0-47a5-8ea0-aa7882a84303prefix: Single Stage
title: Loss on Drying
code: Visual
reason: Loss on Drying
Documentations
Type Label Documentation USP <731> goalId: c40aa176-e6aa-4fe4-869d-6550ee992903
action
id
3510686b-fb93-4980-a41c-0a3754be7f37prefix: Single Stage
title: Readily Carbonizable Sub
code: Visual
reason: Organoleptic, Color of Solution
Documentations
Type Label Documentation USP <271> goalId: b122987d-586c-481b-951c-6202e660158d
action
id
b2e18cc4-f494-4ef0-be34-810d8d4b439bprefix: Single Stage
title: Residue on ignition (Ash)
code: Visual
reason: Residue on Ignition
Documentations
Type Label Documentation USP <281> goalId: 929747ad-e83a-46f0-bbbc-133ee951e819
action
id
d315a1c3-dd93-498d-8ae3-dc0d4b3bec75prefix: Single Stage
title: Substances insoluble in sodium carbonate TS
code: Visual
reason: Foreign and Particulate Matter
Documentations
Type Label Documentation EX-TEST-02 goalId: 8d7c85c2-7a4b-432e-ac94-226f296e4fca
action
id
6ec15bbc-a78a-4351-9ad8-fcf97e839ab9prefix: Single Stage
title: Impurities - Chloride (Cl)
code: FTIR
reason: Impurity, Specified Identified Impurity
Documentations
Type Label Documentation USP <221> goalId: de4f962a-d486-486d-8d84-f2d1635646b4
action
id
fa31b425-896c-4b25-b693-ccdd14e0c8eeprefix: Single Stage
title: Impurities - Sulfate (SO4)
code: FTIR
reason: Impurity, Specified Identified Impurity
Documentations
Type Label Documentation USP <221> goalId: b46dce64-a009-46cd-ab95-21d1d5b4df77
action
id
cef5aa1a-8770-4f78-9bc3-da9f18b77e5cprefix: Single Stage
title: Elemental Impurities - Limits
code: UV
reason: Impurity, Elemental Impurity
Documentations
Type Label Documentation USP <231> goalId: 5566f501-37e1-49fb-8783-b20c074ec0c3
action
id
d5871ee2-8b06-414c-91b4-4b30f5881c8aprefix: Single Stage
title: Limit of Free Salicylic Acid
code: Titration
reason: Impurity, Impurities/Degradation Products/Related Substances
Documentations
Type Label Documentation EX-TEST-03 goalId: db19e3ab-e28b-4477-8bd7-2409093ed5a3
action
id
e192fc72-c4b1-419f-8098-6f65037a3962prefix: Single Stage
title: Organic Volatile Impurities
code: Visual
reason: Impurity, Residual Solvent
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-8d01f8b7667bprefix: Single Stage
title: Assay Dry Basis
code: Visual
reason: Assay, Active Ingredient Content
Documentations
Type Label Documentation EX-TEST-04 goalId: 9100e938-42ff-4004-8473-ed5090d66f3a
action
id
6d1ba5a8-6590-496a-ad6b-ca68cfda2878title: Dissolution - 30 minute
code: Visual
reason: Dissolution
Documentations
Type Label Documentation EX-TEST-05 Actions
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
Entry 3 - fullUrl = urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9
identifier: Example2BeadDrug
combinedPharmaceuticalDoseForm: CAPSULE
route: ORAL
name
productName: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg
type: Non-Proprietary
part
part: OXAZEPAM
type: scientific name
part
part: 30mg
type: OXAZEPAM
part
part: PROPRANOLOL HYDROCHLORIDE
type: scientific name
part
part: 60mg
type: PROPRANOLOL HYDROCHLORIDE
Entry 4 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a
Resource Organization:
Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a
identifier: DUNS/143265222
name: Wunderwerke
Contacts
Address Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478