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

Composition

Provide details about drug substance and drug product components, materials, and Quality reference standards.

Product Composition

Resources

MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
Ingredient	The active ingredient (stelbatalol) and other ingredients that make up the product
SubstanceDefinition	The documented impurities
PackagedProductDefinition	Information about the packaging for the product

Examples

CTD section synthetic source data samples (PDF):

• 3.2.P.1 Description and Composition of the Drug Product

XML and JSON examples of synthetic quality data:

• Product Composition example XML
• Product Composition example JSON

HTML presentation example of synthetic quality data:

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

Drug Reference Standards

Resources

SubstanceDefinition	The substance for which reference standards are being established
Substance	Identifying information about an actual batch of substance (an instance)
PlanDefinition	Describes the reference standards set of tests
ObservationDefinition	Each individual test and acceptance criteria
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.5 Reference Standards or Materials (3.2.P.6 Reference Standards or Materials is similar.)

XML and JSON examples of synthetic quality data:

• Substance Reference Standards or Materials example XML
• Substance Reference Standards or Materials example JSON

HTML presentation example of synthetic quality data:

• Substance Reference Standards or Materials - 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