Analytical Procedures

Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

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

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

CTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic quality data:

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).

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

CTD section samples (PDF):

XML and JSON examples of synthetic quality data:

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).