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

Identification

Details about the drug substance and drug product nomenclature; structure; physicochemical properties; and manufacture.

Product

Drug Product

Resources

Composition	Narrative text section(s)
MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
ManufacturedItemDefinition	Information about the physical packaged medication item, such as a tablet or capsule
Composition	Textual information about the product

Examples

CTD section synthetic source data samples (PDF):

• 3.2.P.2 Pharmaceutical Development
  • 3.2.P.2.2 Drug Product

XML and JSON examples of synthetic quality data:

• Product Identification example XML
• Product Identification example JSON

HTML presentation example of synthetic quality data:

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

Drug Product Microbiological Attributes

Resources

MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
Medication	Describes the batches of the product that underwent testing
DiagnosticReport	Contains all rest results as a group and captures conclusions
Observation	The results of a specific test mentioned in the Observation Definition

Examples

CTD section synthetic source data samples (PDF):

• 3.2.P.2 Pharmaceutical Development
  • 3.2.P.2.5 Microbiological Attributes

XML and JSON examples of synthetic quality data:

• Product Microbiological Attributes Report example XML
• Product Microbiological Attributes Report example JSON

HTML presentation example of synthetic quality data:

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

Drug Product Excipients

Resources

MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
Ingredient	The excipients that make up the drug product
Organization	The company that manufactures the excipients
Substance Definition	Chemical or biological details about substance(s) associated with the ingredient

Examples

CTD section synthetic source data samples (PDF):

• 3.2.P.4 Control of Excipients
  • 3.2.P.4.5 Excipients of Human or Animal Origin
  • 3.2.P.4.6 Novel Excipients

XML and JSON examples of synthetic quality data:

• Product Excipients example XML
• Product Excipients example JSON

HTML presentation example of synthetic quality data:

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

Substance

Drug Substance General Properties

Resources

Substance Definition

Properties of the substance

Examples

CTD section synthetic source data samples (PDF):

• 3.2.S.1 General Information
  • 3.2.S.1.3 General Properties

XML and JSON examples of synthetic quality data:

• Substance General Properties example XML
• Substance General Properties example XML

HTML presentation example of synthetic quality data:

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

Drug Substance: Elucidation of Structure

Resources

SubstanceDefinition	The substance being characterized
Substance	Identifying information about an actual batch of substance (an instance)
PlanDefinition	Describes the tests for the characterization
ObservationDefinition	Each individual stability test and their acceptance criteria
Observation	The results of a specific test mentioned in the ObservationDefinition
DiagnosticReport	Contains all rest 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.3 Characterisation
  • 3.2.S.3.1 Elucidation of Structure and Other Characteristics

XML and JSON examples of synthetic quality data:

• Substance Characterisation example XML
• Substance Characterisation example XML

HTML presentation example of synthetic quality data:

• Substance Characterisation: Elucidation of Structure - 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