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

Analytical Procedures

Details about test methods used to analyze substances and products, including compendial and non-compendial testing.

Product

Resources

MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
SubstanceDefinition	Substances used during the analysis process
PlanDefinition	Describes the analysis process
SpecimenDefinition	Describes the storage conditions and duration for each test
Observation Definition	Each individual analysis test and acceptance criteria; also used to group tests

Examples

CTD section synthetic source data samples (PDF):

• 3.2.P.5 Control of Drug Product
  • 3.2.P.5.2 Analytical Procedures

XML and JSON examples of synthetic quality data:

• Product Analytical Procedure example XML
• Product Analytical Procedure example JSON

HTML presentation examples of synthetic quality data:

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

Substance

Resources

SubstanceDefinition	Substances to be analyzed and also ones used during the analysis process
PlanDefinition	Describes the analysis process
DeviceDefinition	Devices/equipment used during testing
SpecimenDefinition	Describes the storage conditions and duration for each test
Observation Definition	Each individual analysis test and acceptance criteria; also used to group tests

Examples

CTD section samples (PDF):

• 3.2.S.4 Control of Drug Substance
  • 3.2.S.4.2 Analytical Procedures

XML and JSON examples of synthetic quality data:

• Substance Analytical Procedure example XML
• Substance Analytical Procedure example JSON

HTML rendering of synthetic quality data:

• Drug Substance Analytical Procedures - 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