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 https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Container Closure System

Details about primary and secondary packaging components for drug substance and drug product.

Product

Resources

MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
PackagedProductDefinition	Information about the packaging for the drug product

Examples

CTD section synthetic source data samples (PDF):

• 3.2.P.7 Container Closure System

XML and JSON examples of synthetic quality data:

• Product Container Closure example XML
• Product Container Closure example JSON

HTML presentation example of synthetic quality data:

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

Substance

Resources

Substance Definition	Definition of this drug substance itself (Stelbatolol)
Ingredient	Connection to the substance as something manufactured (used here mainly for linkage)
ManufacturedItemDefinition	The substance as a physical type of substance that can be packaged (used here mainly for linkage)
PackagedProductDefinition	Information about the packaging for the drug substance

Examples

CTD section synthetic source data samples (PDF):

• 3.2.S.6 Container Closure System

XML and JSON examples of synthetic quality data:

• Substance Container Closure example XML
• Substance Container Closure example JSON

HTML presentation example of synthetic quality data:

• Substance Container Closure System - 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