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

## Analytical Procedures

Details about test methods used to analyze substances and products, including compendial and non-compendial testing.

### Product

#### Resources

MedicinalProductDefinition | The drug product (Stelbat tablets, 20mg)
SubstanceDefinition | Substances used during the analysis process
PlanDefinition | Describes the analysis process
SpecimenDefinition | Describes the storage conditions and duration for each test
Observation Definition | Each individual analysis test and acceptance criteria; also used to group tests

#### Examples

CTD section synthetic source data samples (PDF):

- 3.2.P.5 Control of Drug Product
  - 3.2.P.5.2 Analytical Procedures

XML and JSON examples of synthetic quality data:

- Product Analytical Procedure example XML
- Product Analytical Procedure example JSON

HTML presentation examples of synthetic quality data:

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

### Substance

#### Resources

SubstanceDefinition | Substances to be analyzed and also ones used during the analysis process
PlanDefinition | Describes the analysis process
DeviceDefinition | Devices/equipment used during testing
SpecimenDefinition | Describes the storage conditions and duration for each test
Observation Definition | Each individual analysis test and acceptance criteria; also used to group tests

#### Examples

CTD section samples (PDF):

- 3.2.S.4 Control of Drug Substance
  - 3.2.S.4.2 Analytical Procedures

XML and JSON examples of synthetic quality data:

- Substance Analytical Procedure example XML
- Substance Analytical Procedure example JSON

HTML rendering of synthetic quality data:

- Drug Substance Analytical Procedures - 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