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

## Compatibility

Details about compatibility studies and results.

### Product

#### Resources

MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg)
Medication | Describes the batches that underwent testing
Ingredient | The active ingredient (stelbatalol) or the ingredients that make up the drug product
SubstanceDefinition | Chemical or biological details about substance(s) associated with the ingredient
PlanDefinition | Describes the compatibility analysis protocol
ObservationDefinition | Each individual test and acceptance criteria; also used to group tests
Observation | The results of a specific test mentioned in the ObservationDefinition
DiagnosticReport | Contains all results as a group and captures conclusions

### Examples

CTD section samples (PDF):

- 3.2.P.2 Pharmaceutical Development
  - 3.2.P.2.6 Compatibility

XML and JSON examples of synthetic quality data:

- Product Compatibility example XML
- Product Compatibility example JSON

HTML rendering of synthetic quality data:

- Drug Product Compatibility - 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