Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
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
Document Content
Entry 1 - fullUrl = urn:uuid:c00b0003-c2bf-7547-8b1c-f1f399f99d5c
Resource Composition:
Generated Narrative: Composition c00b0003-c2bf-7547-8b1c-f1f399f99d5c
identifier: BatchFormulaComposition2layer
status: Final
type: Product Batch Formula
date: 2024-08-01 12:34:56+0000
title: Batch formula example two layer tablet
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:b69435a0-45c6-4d44-9fde-b354e17408d7
Resource Organization:
Generated Narrative: Organization b69435a0-45c6-4d44-9fde-b354e17408d7
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:
Generated Narrative: MedicinalProductDefinition f0f3ff35-5cfa-6617-b8f1-b8167957f53c
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:
Generated Narrative: ManufacturedItemDefinition 8a3e11d9-4323-43c4-be00-8f0ea1837070
identifier: ASPIRIN-ACETAMINOPHEN
status: Active
name: ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets
manufacturedDoseForm: Tablet
manufacturer: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000
property
type: Batch Quantity
value: 2000 1* (Details: UCUM code1 = '1')
property
type: Batch Utilization
value: Development
property
type: Product Part 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
Product Batch Ingredient Extension
- overagePercent: 0.02
- overageJustification:
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:
Generated Narrative: Ingredient d4713a90-38d1-49e5-a977-78c63e518562
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:
Generated Narrative: Ingredient fbd464cc-2511-4a3a-b058-3cec4fffd14f
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:
Generated Narrative: Ingredient 9973ba9a-b257-425a-8fb9-6dcfe379ca08
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:
Generated Narrative: Ingredient 4e394a0c-4b25-492e-aac7-0faf121ffc4f
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:
Generated Narrative: Ingredient 95648837-ec81-42d9-970c-eac390f2f604
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:
Generated Narrative: SubstanceDefinition cbb54715-3928-4e3f-9abe-32914f694957
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 R16CO5Y76E Names
Name Type Preferred ASPIRIN GSRS Preferred Term true
Entry 12 - fullUrl = urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition ca1ff85f-3f05-46be-8cc4-30b076d88c13
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:
Generated Narrative: SubstanceDefinition 99f4a24f-880f-45f1-8364-8e4e03977b2e
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:
Generated Narrative: SubstanceDefinition a4624559-6c4f-4e90-996d-bc3bf2f5a3f4
classification: Mixture
grade: BP
Codes
Code 3GOV20705G Names
Name Type Preferred WINE GRAPE GSRS Preferred Term true SourceMaterials
Type Plant
Entry 15 - fullUrl = urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition 254742fb-7b5b-49f5-b4af-e0d14d81f2f6
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:
Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579
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:
Generated Narrative: Organization e165f057-5eed-4e64-8328-4438fc88fb1b
identifier: DUNS/143265222
name: Vandechemie
Contacts
Address Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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