Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 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: 3.2.P.3.2 Bundle for two-layer tablet

Document Details

Profile: CMC eCTD 32P32 Document

Final Document at 2024-08-01 12:34:56+0000 by Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 for

Document Content

## Batch Formula

## Additional Resources Included in Document

Entry 2 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a

Resource Organization:

> Profile: Basic Organization

> identifier: DUNS/143265222

> name: Wunderwerke

> ### Contacts

> - | Address
> * | Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478

Entry 3 - fullUrl = urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7

Resource Organization:

> Profile: Basic Organization

> identifier: DUNS/143265222

> name: Large Life

> ### Contacts

> - | Address
> * | 123 Broad Way, New York, NY, United States

Entry 4 - fullUrl = urn:uuid:f0f3ff35-5cfa-6617-b8f1-b8167957f53c

Resource MedicinalProductDefinition:

> Profile: Batch Formula Drug Product Identification

> identifier: ASPIRIN-ACETAMINOPHEN-Identification

> combinedPharmaceuticalDoseForm: TABLET, MULTILAYER

> route: ORAL

> comprisedOf: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > name

> > productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg

> > type: Nonproprietary Name

> > > part

> > > part: ASPIRIN

> > > type: scientific name

> > > part

> > > part: 200mg

> > > type: ASPIRIN

> > > part

> > > part: ACETAMINOPHEN

> > > type: scientific name

> > > part

> > > part: 300mg

> > > type: ACETAMINOPHEN

Entry 5 - fullUrl = urn:uuid:8a3e11d9-4323-43c4-be00-8f0ea1837070

Resource ManufacturedItemDefinition:

> Profile: Drug Product Batch Formula

> identifier: ASPIRIN-ACETAMINOPHEN

> status: Active

> name: ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets

> manufacturedDoseForm: Tablet

> manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > property

> > type: Batch Quantity

> > value: 2000 tablets (Details: UCUM code{tbl} = '{tbl}')

> > property

> > type: Batch Utilization

> > value: Development

> > property

> > type: Batch Formula Additional Information

> > value:

> > Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation

> > component

> > type: Layer

> > amount: 925.97 gram (Details: UCUM codeg = 'g'), 38.55 percent (Details: UCUM code% = '%')

> > > constituent

> > > amount: 400 gram (Details: UCUM codeg = 'g'), 43.1 percent (Details: UCUM code% = '%')

> > > location: Purple Layer

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > constituent

> > > amount: 524.01 gram (Details: UCUM codeg = 'g'), 56.59 percent (Details: UCUM code% = '%')

> > > location: Purple Layer

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > constituent

> > > amount: 203.71 gram (Details: UCUM codeg = 'g'), 22 percent (Details: UCUM code% = '%')

> > > location: Purple Layer

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > constituent

> > > > Overage Extension

> > > > - proportionDecimal: 0.02
> > > > - justification:

> > > Evaporation

> > > amount: 311.68 gram (Details: UCUM codeg = 'g'), 33 percent (Details: UCUM code% = '%')

> > > location: Purple Layer

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > ### Properties

> > - | Type | Value[x]
> > * | Product Part Identifier | Purple Layer

> > component

> > type: Layer

> > amount: 1476.03 gram (Details: UCUM codeg = 'g'), 61.45 percent (Details: UCUM code% = '%')

> > > constituent

> > > amount: 600.01 gram (Details: UCUM codeg = 'g'), 40.65 percent (Details: UCUM code% = '%')

> > > location: Example1Drug_LayerB

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > constituent

> > > amount: 876.02 gram (Details: UCUM codeg = 'g'), 59.35 percent (Details: UCUM code% = '%')

> > > location: Example1Drug_LayerB

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > constituent

> > > amount: 369.01 gram (Details: UCUM codeg = 'g'), 25 percent (Details: UCUM code% = '%')

> > > location: Example1Drug_LayerB

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > ### Properties

> > - | Type | Value[x]
> > * | Product Part Identifier | Example1Drug_LayerB

Entry 6 - fullUrl = urn:uuid:d4713a90-38d1-49e5-a977-78c63e518562

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: Asprin - Ingredient

> status: Active

> role: Active Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > strength

> > > concentration: 400 gram (Details: UCUM codeg = 'g')

> > > strength

> > > concentration: 10.4 percent (Details: UCUM code% = '%')

Entry 7 - fullUrl = urn:uuid:fbd464cc-2511-4a3a-b058-3cec4fffd14f

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: AcetaminophenIngredient

> status: Active

> role: Active Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > strength

> > > concentration: 600 gram (Details: UCUM codeg = 'g')

> > > strength

> > > concentration: 25 percent (Details: UCUM code% = '%')

Entry 8 - fullUrl = urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: MaizeStarchIngredient

> status: Active

> role: Inactive Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > strength

> > > concentration: 1400.03 gram (Details: UCUM codeg = 'g')

> > > strength

> > > concentration: 58.28 percent (Details: UCUM code% = '%')

Entry 9 - fullUrl = urn:uuid:4e394a0c-4b25-492e-aac7-0faf121ffc4f

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: GrapeskinIngredient

> status: Active

> role: Inactive Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > strength

> > > concentration: 203.71 gram (Details: UCUM codeg = 'g')

> > > strength

> > > concentration: 8.48 percent (Details: UCUM code% = '%')

Entry 10 - fullUrl = urn:uuid:95648837-ec81-42d9-970c-eac390f2f604

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: WaterBFIngredient

> status: Active

> role: Inactive Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> > > strength

> > > concentration: 50.75 kilogram (Details: UCUM codekg = 'kg')

> > > strength

> > > concentration: 95.3572 percent (Details: UCUM code% = '%')

Entry 11 - fullUrl = urn:uuid:cbb54715-3928-4e3f-9abe-32914f694957

Resource SubstanceDefinition:

> Profile: Drug Substance Handle

> classification: Chemical

> grade: USP-NF

> manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> ### Codes

> - | Code
> * | R16CO5Y76E

> ### Names

> - | Name | Type | Preferred
> * | ASPIRIN | GSRS Preferred Term | true

Entry 12 - fullUrl = urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13

Resource SubstanceDefinition:

> Profile: Drug Substance Handle

> classification: Chemical

> grade: USP-NF

> manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

> ### Codes

> - | Code
> * | 362O9ITL9D

> ### Names

> - | Name | Type | Preferred
> * | ACETAMINOPHEN | GSRS Preferred Term | true

Entry 13 - fullUrl = urn:uuid:99f4a24f-880f-45f1-8364-8e4e03977b2e

Resource SubstanceDefinition:

> Profile: Excipient Drug Substance

> classification: Mixture

> grade: Company Standard

> ### Codes

> - | Code
> * | O8232NY3SJ

> ### Names

> - | Name | Type | Preferred
> * | STARCH, CORN | GSRS Preferred Term | true

> ### SourceMaterials

> - | Type
> * | Chemical

Entry 14 - fullUrl = urn:uuid:a4624559-6c4f-4e90-996d-bc3bf2f5a3f4

Resource SubstanceDefinition:

> Profile: Excipient Drug Substance

> classification: Mixture

> grade: BP

> ### Codes

> - | Code
> * | 3GOV20705G

> ### Names

> - | Name | Type | Preferred
> * | WINE GRAPE | GSRS Preferred Term | true

> ### SourceMaterials

> - | Type | Genus | Species | Part | CountryOfOrigin
> * | Plant | vitis | vinifera | fruit skin | Italy

Entry 15 - fullUrl = urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6

Resource SubstanceDefinition:

> Profile: Excipient Drug Substance

> classification: Chemical

> grade: USP-NF

> ### Codes

> - | Code
> * | 059QF0KO0R

> ### Names

> - | Name | Type | Preferred
> * | WATER | GSRS Preferred Term | true

> ### SourceMaterials

> - | Type
> * | Chemical

Entry 16 - fullUrl = urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579

Resource Organization:

> Profile: Basic Organization

> identifier: DUNS/783452221, FEI/6913973

> name: Manufacturing Site (J. Jones Research)

> ### Contacts

> - | Address
> * | Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States

Entry 17 - fullUrl = urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b

Resource Organization:

> Profile: Basic Organization

> identifier: DUNS/143265222

> name: Vandechemie

> ### Contacts

> - | Address
> * | Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium