FHIR Document example of 3.2.P.5.1. - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v2.0.0-ballot

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 2.0.0-ballot 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

Example Bundle: FHIR Document example of 3.2.P.5.1.

Document Details

Generated Narrative: Bundle Quality Specification for an example Drug Product

Document Content

32P51

Additional Resources Included in Document

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: Specification(s)
date: 2023-12-15 22:33:13+0000
author: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+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
subject: Bundle: identifier = UUID:34a0748d-b199-4a2e-a5bc-0f880886fef7; type = document; timestamp = 2023-12-15 22:33:13+0000
date: 2022-12-08
goal
id
32649771-1290-4386-9cf7-7a72274f22b4
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addresses: Release, Stability
Targets
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*
goal
id
59a4ca76-858e-4d58-8e5f-88e75f51ec33
description: Maxima only at the same wavelengths compared to reference standard
addresses: Release, Stability
Targets
- Detail[x]
* Conforms
goal
id
c40aa176-e6aa-4fe4-869d-6550ee992903
description: <= 0.5 %
addresses: Release, Stability
Targets
- Detail[x]
* <=0.5 percent (Details: UCUM code% = '%')
goal
id
b122987d-586c-481b-951c-6202e660158d
description: Color of solution is clear
addresses: Release, Stability
Targets
- Detail[x]
* Conforms
goal
id
929747ad-e83a-46f0-bbbc-133ee951e819
description: <= 0.05 %
addresses: Release, Stability
Targets
- Detail[x]
* <=0.05 percent (Details: UCUM code% = '%')
goal
id
8d7c85c2-7a4b-432e-ac94-226f296e4fca
description: No Particulate Matter detected
addresses: Release, Stability
Targets
- Detail[x]
* pass
goal
id
de4f962a-d486-486d-8d84-f2d1635646b4
description: <= 0.014 %
addresses: Release, Stability
Targets
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* <=0.014 percent (Details: UCUM code% = '%')
goal
id
b46dce64-a009-46cd-ab95-21d1d5b4df77
description: <= 0.04 %
addresses: Release, Stability
Targets
- Detail[x]
* <=0.04 percent (Details: UCUM code% = '%')
goal
id
5566f501-37e1-49fb-8783-b20c074ec0c3
description: <= 0.001 %
addresses: Release, Stability
Targets
- Detail[x]
* <=0.001 percent (Details: UCUM code% = '%')
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, Stability
Targets
- Detail[x]
* pass
goal
id
82370588-7aae-4556-9262-a7f50dbd01aa
description: Ethanol < 0.2%
addresses: Release, Stability
Targets
- Measure Detail[x]
* Ethanol <=0.2 percent (Details: UCUM code% = '%')
goal
id
cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2
description: Ethyl Ether < 0.1%
addresses: Release
Targets
- Measure Detail[x]
* Ethyl Ether <=0.1 percent (Details: UCUM code% = '%')
goal
id
28ad4d5b-d975-4f6e-9792-b3d9cc7ce279
description: 1—propanol < 0.15%
addresses: Release
Targets
- Measure Detail[x]
* 1—propanol <=0.15 percent (Details: UCUM code% = '%')
goal
id
33fa051c-6b3c-4e4d-bd4e-09d39fc253b3
description: Total < 0.5%
addresses: Release
Targets
- Measure Detail[x]
* Total Residual Solvents <=0.5 percent (Details: UCUM code% = '%')
goal
id
9100e938-42ff-4004-8473-ed5090d66f3a
description: 99.5 - 100.5 %
addresses: Release, Stability
Targets
- ModifierExtension
*
goal
id
af260128-f105-4692-ba40-49f21f12ad46
description: n=6
addresses: Release
Targets
- Detail[x]
* 6
goal
id
31d9dcac-bf72-420b-a415-c924155a83f4
description: Each unit is NLT Q + 5%
addresses: Release
Targets
- Detail[x]
* <=85 percent (Details: UCUM code% = '%')
goal
id
47c0d685-0b23-4637-9af8-a554e4fad7ec
description: n=6
addresses: Release
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
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-aee1-452d6d2f7a91
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
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-bd29-4263-9ae2-2391106326bb
description: n=12
addresses: Release
Targets
- Detail[x]
* 12
action
id
2047a6b6-e3fc-4071-8989-526297579091
prefix: Single Stage
title: Spectrophotometry Identification
description:
Alternate

code: Spectrophotometry
reason: Identification
Documentations
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RelatedActions
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action
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linkId: 2047a6b6-e3fc-4071-8989-526297579091
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description:
Alternate

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Documentations
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action
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Documentations
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action
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reason: Impurity, Specified Identified Impurity
Documentations
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goalId: de4f962a-d486-486d-8d84-f2d1635646b4
action
id
fa31b425-896c-4b25-b693-ccdd14e0c8ee
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reason: Impurity, Specified Identified Impurity
Documentations
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goalId: b46dce64-a009-46cd-ab95-21d1d5b4df77
action
id
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code: UV
reason: Impurity, Elemental Impurity
Documentations
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goalId: 5566f501-37e1-49fb-8783-b20c074ec0c3
action
id
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prefix: Single Stage
title: Limit of Free Salicylic Acid
code: Titration
reason: Impurity, Impurities/Degradation Products/Related Substances
Documentations
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goalId: db19e3ab-e28b-4477-8bd7-2409093ed5a3
action
id
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reason: Impurity, Residual Solvent
Documentations
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action
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Documentations
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action
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6d1ba5a8-6590-496a-ad6b-ca68cfda2878
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reason: Dissolution
Documentations
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Actions
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* 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