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

## Process Validation

Details about manufacturing process validation protocols and results.

### 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
Medication | Describes the batches that underwent testing
PlanDefinition | Describes the process validation protocol
ObservationDefinition | Each individual test and acceptance criteria; also used to group closely related tests
ActivityDefinition | Used to group tests such as by timings
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
Procedure | (not illustrated above): Records the actual performance of a manufacturing step, so that measurements can be recorded via Observations (e.g., “hold time”, “bioburden”)
Substance | Identifying information about an actual batch of substance (an instance)

#### Examples

CTD section synthetic source data samples (PDF):

- 3.2.P.3 Manufacture
  - 3.2.P.3.5 Process Validation and/or Evaluation
  - 3.2.P.3.5 Process Validation and/or Evaluation - Biologic Example

XML and JSON examples of synthetic quality data:

- Product Process Validation example XML
- Product Process Validation example JSON
- Product Process Validation Biological example XML
- Product Process Validation Biological example JSON

HTML presentation example of synthetic quality data:

- Drug Product Process Validation
- Drug Product Process Validation - Biologic

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

### Substance

#### Resources

SubstanceDefinition | Chemical or biological details about substance(s) associated with the ingredient
Substance | Identifying information about an actual batch of substance (an instance)
PlanDefinition | Describes the process validation protocol
ObservationDefinition | Each individual test and acceptance criteria; also used to group closely related tests
ActivityDefinition | Used to group tests such as by timings
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.2 Manufacture
  - 3.2.S.2.5 Process Validation and/or Evaluation

XML and JSON examples of synthetic quality data:

- Substance Process Validation example XML
- Substance Process Validation example JSON

HTML presentation example of synthetic quality data:

- Substance Process Validation - 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