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

Batch Formula

Details about drug product master batch properties and formula.



MedicinalProductDefinitionThe drug product (Stelbat tablets, 20mg)
MedicationDescribes the batch instances themselves, and quantities of ingredients
SubstanceThe substance used as in ingredient for this batch
SubstanceDefinitionChemical or biological details about substance(s) associated with the ingredient


CTD section samples (PDF):

XML and JSON examples of synthetic quality data:

HTML rendering of synthetic quality data:

  • Drug Product Batch Formula - 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