Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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

Example Bundle: Example Batch Formula bundle

Document Details

Generated Narrative: Bundle Batch formula example


Document Content

Batch Formula


Additional Resources Included in Document


Entry 1 - fullUrl = urn:uuid:0003c00b-bfc2-4775-8b1c-9f99d5cf1f39

Resource Composition:

Generated Narrative: Composition 0003c00b-bfc2-4775-8b1c-9f99d5cf1f39

identifier: BatchFormulaComposition

status: Final

type: Product Batch Formula

date: 2024-07-01 12:34:56+0000

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

title: Batch formula example


Entry 2 - 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

Entry 3 - fullUrl = urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501

Resource Organization:

Generated Narrative: Organization e875ef93-a730-4c44-bead-53663ae7f501

identifier: DUNS/143265222, 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:

Generated Narrative: MedicinalProductDefinition d0d2df25-5cfa-4417-b8d1-b8147957f53c

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: Non-Proprietary

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:

Generated Narrative: ManufacturedItemDefinition 249ef22b-d521-4304-a388-6b9035f97b22

identifier: Oxazepam-Propranolol-BatchFormula

status: Active

name: ATOMOXETINE HYDROCHLORIDE 1mg

manufacturedDoseForm: Liquid

manufacturer: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000

property

type: Batch Quantity

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

property

type: Batch Utilization

value: Commercial

property

type: Product Part 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

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

-TypeValue[x]
*Product Part Identifiersolution

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

Resource Ingredient:

Generated Narrative: Ingredient 1c1a2a23-1fd7-4487-9682-49877f9f9f77

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:

Generated Narrative: SubstanceDefinition 717d868e-6696-4ebb-adf4-63eadb3bf058

classification: Chemical

grade: USP-NF

manufacturer: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000

Codes

-Code
*57WVB6I2W0

Names

-NameTypePreferred
*ATOMOXETINE HYDROCHLORIDEGSRS Preferred Termtrue

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

Resource Ingredient:

Generated Narrative: Ingredient 12cce82f-8595-4860-b7ca-06c9ec0327f2

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:

Generated Narrative: SubstanceDefinition 45942749-64db-4f91-88c3-51adb680fed1

classification: Chemical

grade: USP-NF

Codes

-Code
*Q40Q9N063P

Names

-NameTypePreferred
*ACETIC ACIDGSRS Preferred Termtrue

SourceMaterials

-Type
*Chemical

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

Resource Ingredient:

Generated Narrative: Ingredient 45eb4f05-83d9-4819-bb60-96c7c5ce2b76

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:

Generated Narrative: SubstanceDefinition 07c598ee-3dcf-45b7-b4e5-b24812c22aff

classification: Chemical

grade: USP-NF

Codes

-Code
*NVG71ZZ7P0

Names

-NameTypePreferred
*SODIUM ACETATE ANHYDROUSGSRS Preferred Termtrue

SourceMaterials

-Type
*Chemical

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

Resource Ingredient:

Generated Narrative: Ingredient 29c0ee76-f62f-41d3-b761-73d5f205e552

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:

Generated Narrative: SubstanceDefinition a339a562-e325-4ce6-a830-d25c27b5e2da

classification: Chemical

grade: USP-NF

Codes

-Code
*3OWL53L36A

Names

-NameTypePreferred
*MANNITOLGSRS Preferred Termtrue

SourceMaterials

-Type
*Chemical

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

Resource Ingredient:

Generated Narrative: Ingredient 44fad9fd-826a-4f0c-9f25-e0a78d1c4269

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:

Generated Narrative: SubstanceDefinition c75df5fb-e962-43a6-9dd3-c6682da10a7e

classification: Chemical

grade: USP-NF

Codes

-Code
*GGO4Y809LO

Names

-NameTypePreferred
*METACRESOLGSRS Preferred Termtrue

SourceMaterials

-Type
*Chemical

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

Resource Ingredient:

Generated Narrative: Ingredient d0574580-7694-4a36-8a27-5bdbccfc5557

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:

Generated Narrative: SubstanceDefinition c4e5b7c6-2e52-48e3-813b-d227cf29329b

classification: Chemical

grade: USP-NF

Codes

-Code
*059QF0KO0R

Names

-NameTypePreferred
*WATERGSRS Preferred Termtrue

SourceMaterials

-Type
*Chemical