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