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

Stability Study

Details about a stability study including stability study design (tests and acceptance criteria), drug substance or drug product batches involved, test results, and conclusion.

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 stability testing
PlanDefinition	Describes the stability study protocol
ActivityDefinition	Used to group tests such as by timings
ObservationDefinition	Each individual test and acceptance criteria; also used to group closely related tests
Specimen	(not illustrated above) Identifying information about an individual specimen (an instance)
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.P.8 Stability
  • 3.2.P.8.1 Stability Summary and Conclusions
  • 3.2.P.8.3 Stability Data

XML and JSON examples of synthetic quality data:

• Product Stability example XML
• Product Stability example JSON

HTML presentation example of synthetic quality data:

• Drug Product Stability - 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 being tested
Substance	Identifying information about an actual batch of substance being tested (an instance)
PlanDefinition	Describes the stability study protocol
ActivityDefinition	Used to group tests such as by timings
ObservationDefinition	Each individual test and acceptance criteria; also used to group closely related tests
SpecificationDefinition	Describes the storage conditions and duration for each test
Specimen	(not illustrated above) Identifying information about an individual specimen (an instance)
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
Substance	Identifying information about an actual batch of substance (an instance)

Examples

CTD section synthetic source data samples (PDF):

• 3.2.S.7 Stability
  • 3.2.S.7.1 Stability Summary and Conclusions
  • 3.2.S.7.3 Stability Data

XML and JSON examples of synthetic quality data:

• Substance Stability example XML
• Substance Stability example JSON

HTML presentation example of synthetic quality data:

• Drug Substance Stability - 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