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

## Impurities

Details about impurity identification and characterization.

### Product

#### Resources

MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg)
SubstanceDefinition | The documented impurities
Medication | Describes the batches of the product that underwent testing for impurities
Observation | The results of testing for impurities in the batches
Organization | The company/site that performed the testing, or manufactured the batch
DiagnosticReport | Contains all results as a group, with conclusions

#### Examples

CTD section synthetic source data samples (PDF):

- 3.2.P.5 Control of Drug Product
  - 3.2.P.5.5 Characterisation of Impurities

XML and JSON examples of synthetic quality data:

- Product Impurities example XML
- Product Impurities example JSON

HTML presentation example of synthetic quality data:

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

### Substance

#### Resources

SubstanceDefinition | The substance itself and its impurities as substances
DocumentReference | Image files e.g. for molecular structure

#### Examples

CTD section synthetic source data samples (PDF):

- 3.2.S.3 Characterisation
  - 3.2.S.3.2 Impurities

XML and JSON examples of synthetic quality data:

- Substance Impurities example XML
- Substance Impurities example JSON

HTML presentation example of synthetic quality data:

- Substance Impurities example HTML - 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