Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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 and changes regularly. See the Directory of published versions


Details about compatibility studies and results.



MedicinalProductDefinitionThe drug product (Stelbat tablets, 20mg)
MedicationDescribes the batches that underwent testing
IngredientThe active ingredient (stelbatalol) or the ingredients that make up the drug product
SubstanceDefinitionChemical or biological details about substance(s) associated with the ingredient
PlanDefinitionDescribes the compatibility analysis protocol
ObservationDefinitionEach individual test and acceptance criteria; also used to group tests
ObservationThe results of a specific test mentioned in the ObservationDefinition
DiagnosticReportContains all results as a group and captures conclusions


CTD section samples (PDF):

XML and JSON examples of synthetic quality data:

HTML rendering of synthetic quality data:

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


See Artifacts Index: Domain Bundle Profiles