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 liquid

Document Details

Profile: CMC eCTD 32P32 Document

Final Document at 2024-07-01 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:e875ef93-a730-4c44-bead-53663ae7f501

Resource Organization:

> Profile: Basic Organization

> identifier: DUNS/147275722, FEI/6981397

> name: East-West Manufacturing

> ### Contacts

> - | Address
> * | East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States

Entry 4 - fullUrl = urn:uuid:d0d2df25-5cfa-4417-b8d1-b8147957f53c

Resource MedicinalProductDefinition:

> Profile: Batch Formula Drug Product Identification

> identifier: Oxazepam-Propranolol-BatchFormula-Identification

> combinedPharmaceuticalDoseForm: LIQUID

> route: ORAL

> comprisedOf: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > name

> > productName: ATOMOXETINE HYDROCHLORIDE 1mg

> > type: Nonproprietary Name

> > > part

> > > part: ATOMOXETINE HYDROCHLORIDE

> > > type: scientific name

> > > part

> > > part: 1mg

> > > type: ATOMOXETINE HYDROCHLORIDE

Entry 5 - fullUrl = urn:uuid:249ef22b-d521-4304-a388-6b9035f97b22

Resource ManufacturedItemDefinition:

> Profile: Drug Product Batch Formula

> identifier: Oxazepam-Propranolol-BatchFormula

> status: Active

> name: ATOMOXETINE HYDROCHLORIDE 1mg

> manufacturedDoseForm: Liquid

> manufacturer: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > property

> > type: Batch Quantity

> > value: 50 liter (Details: UCUM codeL = 'L')

> > property

> > type: Batch Utilization

> > value: Commercial

> > property

> > type: Batch Formula Additional Information

> > value:

> > Makes 50 Litres of product, accounting for losses from evaporation and spillage

> > component

> > type: Solution

> > amount: 53.2 kilogram (Details: UCUM codekg = 'kg'), 100 percent (Details: UCUM code% = '%')

> > > constituent

> > > Product Batch Strength Textual Extension: 5% atomexetine hydrochloride solution

> > > amount: 25.42 gram (Details: UCUM codeg = 'g'), 0.0477 percent (Details: UCUM code% = '%')

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > constituent

> > > amount: 20.5 gram (Details: UCUM codeg = 'g'), 0.0385 percent (Details: UCUM code% = '%')

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > constituent

> > > amount: 5 gram (Details: UCUM codeg = 'g'), 0.0094 percent (Details: UCUM code% = '%')

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > constituent

> > > amount: 2.27 kilogram (Details: UCUM codekg = 'kg'), 4.2652 percent (Details: UCUM code% = '%')

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > constituent

> > > amount: 150 gram (Details: UCUM codeg = 'g'), 0.2818 percent (Details: UCUM code% = '%')

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > constituent

> > > amount: 50.75 kilogram (Details: UCUM codekg = 'kg'), 95.3572 percent (Details: UCUM code% = '%')

> > > ### HasIngredients

> > > - | Reference
> > > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > ### Properties

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

Entry 6 - fullUrl = urn:uuid:1c1a2a23-1fd7-4487-9682-49877f9f9f77

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: AtomexetineHydrochlorideBFIngredient

> status: Active

> role: Active Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > strength

> > > concentration: 25.42 gram (Details: UCUM codeg = 'g')

> > > strength

> > > concentration: 0.0477 percent (Details: UCUM code% = '%')

Entry 7 - fullUrl = urn:uuid:717d868e-6696-4ebb-adf4-63eadb3bf058

Resource SubstanceDefinition:

> Profile: Drug Substance Handle

> classification: Chemical

> grade: USP-NF

> manufacturer: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> ### Codes

> - | Code
> * | 57WVB6I2W0

> ### Names

> - | Name | Type | Preferred
> * | ATOMOXETINE HYDROCHLORIDE | GSRS Preferred Term | true

Entry 8 - fullUrl = urn:uuid:12cce82f-8595-4860-b7ca-06c9ec0327f2

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: GlacialAceticAcidBFIngredient

> status: Active

> role: Inactive Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > strength

> > > concentration: 20.5 gram (Details: UCUM codeg = 'g')

> > > strength

> > > concentration: 0.0385 percent (Details: UCUM code% = '%')

Entry 9 - fullUrl = urn:uuid:45942749-64db-4f91-88c3-51adb680fed1

Resource SubstanceDefinition:

> Profile: Excipient Drug Substance

> classification: Chemical

> grade: USP-NF

> ### Codes

> - | Code
> * | Q40Q9N063P

> ### Names

> - | Name | Type | Preferred
> * | ACETIC ACID | GSRS Preferred Term | true

> ### SourceMaterials

> - | Type
> * | Chemical

Entry 10 - fullUrl = urn:uuid:45eb4f05-83d9-4819-bb60-96c7c5ce2b76

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: AnhydrousSodiumAcetateBFIngredient

> status: Active

> role: Inactive Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > strength

> > > concentration: 5 gram (Details: UCUM codeg = 'g')

> > > strength

> > > concentration: 0.0094 percent (Details: UCUM code% = '%')

Entry 11 - fullUrl = urn:uuid:07c598ee-3dcf-45b7-b4e5-b24812c22aff

Resource SubstanceDefinition:

> Profile: Excipient Drug Substance

> classification: Chemical

> grade: USP-NF

> ### Codes

> - | Code
> * | NVG71ZZ7P0

> ### Names

> - | Name | Type | Preferred
> * | SODIUM ACETATE ANHYDROUS | GSRS Preferred Term | true

> ### SourceMaterials

> - | Type
> * | Chemical

Entry 12 - fullUrl = urn:uuid:29c0ee76-f62f-41d3-b761-73d5f205e552

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: MannitolBFIngredient

> status: Active

> role: Inactive Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > strength

> > > concentration: 2.27 kilogram (Details: UCUM codekg = 'kg')

> > > strength

> > > concentration: 4.2652 percent (Details: UCUM code% = '%')

Entry 13 - fullUrl = urn:uuid:a339a562-e325-4ce6-a830-d25c27b5e2da

Resource SubstanceDefinition:

> Profile: Excipient Drug Substance

> classification: Chemical

> grade: USP-NF

> ### Codes

> - | Code
> * | 3OWL53L36A

> ### Names

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

> ### SourceMaterials

> - | Type
> * | Chemical

Entry 14 - fullUrl = urn:uuid:44fad9fd-826a-4f0c-9f25-e0a78d1c4269

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: MetacresolBFIngredient

> status: Active

> role: Inactive Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > strength

> > > concentration: 150 gram (Details: UCUM codeg = 'g')

> > > strength

> > > concentration: 0.2818 percent (Details: UCUM code% = '%')

Entry 15 - fullUrl = urn:uuid:c75df5fb-e962-43a6-9dd3-c6682da10a7e

Resource SubstanceDefinition:

> Profile: Excipient Drug Substance

> classification: Chemical

> grade: USP-NF

> ### Codes

> - | Code
> * | GGO4Y809LO

> ### Names

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

> ### SourceMaterials

> - | Type
> * | Chemical

Entry 16 - fullUrl = urn:uuid:d0574580-7694-4a36-8a27-5bdbccfc5557

Resource Ingredient:

> Profile: Drug Product Batch Formula Ingredient

> identifier: WaterBFIngredient

> status: Active

> role: Inactive Ingredient

> > substance

> > ### Codes

> > - | Reference
> > * | Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000

> > > strength

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

> > > strength

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

Entry 17 - fullUrl = urn:uuid:c4e5b7c6-2e52-48e3-813b-d227cf29329b

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