Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Batch Formula

Details about drug product master batch properties and formula.

Product

Resources

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

Examples

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).

Profiles

See Artifacts Index: Domain Bundle Profiles