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

## Composition

Provide details about drug substance and drug product components, materials, and Quality reference standards.

### Product Composition

#### Resources

MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg)
Ingredient | The active ingredient (stelbatalol) and other ingredients that make up the product
SubstanceDefinition | The documented impurities
PackagedProductDefinition | Information about the packaging for the product

#### Examples

CTD section synthetic source data samples (PDF):

- 3.2.P.1 Description and Composition of the Drug Product

XML and JSON examples of synthetic quality data:

- Product Composition example XML
- Product Composition example JSON

HTML presentation example of synthetic quality data:

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

### Drug Reference Standards

#### Resources

SubstanceDefinition | The substance for which reference standards are being established
Substance | Identifying information about an actual batch of substance (an instance)
PlanDefinition | Describes the reference standards set of tests
ObservationDefinition | Each individual test and acceptance criteria
Observation | The results of a specific test mentioned in the ObservationDefinition
DiagnosticReport | Contains all results as a group and captures conclusions
Organization | (not illustrated above): The company/site that performed the testing or manufacturing

#### Examples

CTD section synthetic source data samples (PDF):

- 3.2.S.5 Reference Standards or Materials (3.2.P.6 Reference Standards or Materials is similar.)

XML and JSON examples of synthetic quality data:

- Substance Reference Standards or Materials example XML
- Substance Reference Standards or Materials example JSON

HTML presentation example of synthetic quality data:

- Substance Reference Standards or Materials - 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