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: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
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: 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:
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
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:
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
Name Type Preferred ATOMOXETINE HYDROCHLORIDE GSRS Preferred Term true
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
Name Type Preferred ACETIC ACID GSRS Preferred Term true 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
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:
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
Name Type Preferred MANNITOL GSRS Preferred Term true 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
Name Type Preferred METACRESOL GSRS Preferred Term true 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
Name Type Preferred WATER GSRS Preferred Term true SourceMaterials
Type Chemical
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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