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

Batch Analysis

Details about drug substance and drug product batch release testing and results.

Product

Resources

MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
Medication	Describes the batches that underwent testing
Ingredient	The active ingredient (stelbatalol) or the ingredients that make up the drug product
SubstanceDefinition	Chemical or biological details about substance(s) associated with the ingredient
PlanDefinition	Describes the batch analysis protocol
ObservationDefinition	Each individual test and acceptance criteria; also used to group tests
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.P.5 Control of Drug Product
  • 3.2.P.5.4 Batch Analyses

XML and JSON examples of synthetic quality data:

• Product Batch Analysis example XML
• Product Batch Analysis example JSON

HTML presentation example of synthetic quality data:

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

Substance

Resources

SubstanceDefinition	The substance being tested
Substance	Identifying information about an actual batch of substance being tested (an instance)
PlanDefinition	Describes the batch analysis protocol
ObservationDefinition	Each individual test and acceptance criteria; also used to group tests
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.4 Control of Drug Substance
  • 3.2.S.4.4 Batch Analyses

XML and JSON examples of synthetic quality data:

• Substance Batch Analysis example XML
• Substance Batch Analysis example JSON

HTML presentation example of synthetic quality data:

• Substance Batch Analyses - 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