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

## Drug Specification

Details about drug substance or drug product release and stability specification (tests, acceptance criteria).

### Product

#### Resources

MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg)
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 specification set of tests
ObservationDefinition | Each individual test and acceptance criteria; also used to group closely related tests
Organization | (not illustrated above): The company/site that performed the testing or manufacturing

#### Examples

CTD section synthetic source data samples (PDF):

- 3.2.P.5 Control of Drug Product
  - 3.2.P.5.1 Specification(s)

XML and JSON examples of synthetic quality data:

- Product Specification example XML
- Product Specification example JSON

HTML presentation example of synthetic quality data:

- Product Specification - 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 which this is a specification for
PlanDefinition | Describes the specification set of tests
ObservationDefinition | Each individual test and acceptance criteria; also used to group closely related tests

#### Examples

CTD section synthetic source data samples (PDF):

- 3.2.S.4 Control of Drug Substance
  - 3.2.S.4.1 Specification

XML and JSON examples of synthetic quality data:

- Substance Specification example XML
- Substance Specification example JSON

HTML presentation example of synthetic quality data:

- Substance Specification - 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