This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, 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

eCTD 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 CTD data:

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

HTML presentation examples of synthetic CTD data:

• Drug Product Analytical Procedures

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 CTD data:

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

HTML rendering of synthetic CTD data:

• Drug Substance Analytical Procedures

Profiles

See Artifacts Index: Analytical Procedure