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 ManufacturedItemDefinition: Batch Formula for Oxazepam / Propranolol-Hydrochloride product

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