Batch Analysis

Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

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

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

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

eCTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic CTD data:

HTML presentation example of synthetic CTD data:

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

eCTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic CTD data:

HTML presentation example of synthetic CTD data: