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-ballot 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

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 impurites
PackagedProductDefinition	Information about the packaging for the product

Examples

eCTD section synthetic source data samples (PDF):

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

XML and JSON examples of synthetic CTD data:

• Product Composition example XML
• Product Composition example JSON

HTML presentation example of synthetic CTD data:

• Drug Substance Reference Standards or Materials

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

eCTD 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 CTD data:

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

HTML presentation example of synthetic CTD data:

• Substance Reference Standards or Materials

Profiles

See Artifacts Index: Composition