Pharmaceutical Quality (Industry)
1.0.0 - STU1

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

## Batch Formula

Details about drug product master batch properties and formula.

### Product

#### Resources

MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg)
Medication | Describes the batch instances themselves, and quantities of ingredients
Substance | The substance used as in ingredient for this batch
SubstanceDefinition | Chemical or biological details about substance(s) associated with the ingredient

### Examples

CTD section samples (PDF):

- 3.2.P.3 Manufacture
  - 3.2.P.3.2 Batch Formula

XML and JSON examples of synthetic quality data:

- Batch Formula example XML
- Batch Formula example JSON

HTML rendering of synthetic quality data:

- Drug Product Batch Formula - Note that HTML examples represent ways to create human-readable output using structured quality data (see section 1.2 Scope).

### Profiles

See Artifacts Index: Domain Bundle Profiles