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

Drug Specification

Details about drug substance or drug product release and stability specification (tests, acceptance criteria).

Product

Resources

MedicinalProductDefinition	The drug product (Stelbat tablets, 20mg)
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 specification set of tests
ObservationDefinition	Each individual test and acceptance criteria; also used to group closely related tests
Organization	(not illustrated above): The company/site that performed the testing or manufacturing

Examples

eCTD section synthetic source data samples (PDF):

• 3.2.P.5 Control of Drug Product
  • 3.2.P.5.1 Specification(s)

XML and JSON examples of synthetic CTD data:

• Product Specification example XML
• Product Specification example JSON

HTML presentation example of synthetic CTD data:

• Product Specification

Substance

Resources

SubstanceDefinition	The substance which this is a specification for
PlanDefinition	Describes the specification set of tests
ObservationDefinition	Each individual test and acceptance criteria; also used to group closely related tests

Examples

eCTD section synthetic source data samples (PDF):

• 3.2.S.4 Control of Drug Substance
  • 3.2.S.4.1 Specification

XML and JSON examples of synthetic CTD data:

• Substance Specification example XML
• Substance Specification example JSON

HTML presentation example of synthetic CTD data:

• Substance Specification

Profiles

See Artifacts Index: Drug Specification