Pharmaceutical Quality (Industry)
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Batch Analysis

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

Product

Resources

MedicinalProductDefinitionThe drug product (Stelbat tablets, 20mg)
MedicationDescribes the batches that underwent testing
IngredientThe active ingredient (stelbatalol) or the ingredients that make up the drug product
SubstanceDefinitionChemical or biological details about substance(s) associated with the ingredient
PlanDefinitionDescribes the batch analysis protocol
ObservationDefinitionEach individual test and acceptance criteria; also used to group tests
ObservationThe results of a specific test mentioned in the ObservationDefinition
DiagnosticReportContains all results as a group and captures conclusions
Organization(not illustrated above): The company/site that performed the testing or manufacturing

Examples

eCTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic CTD data:

HTML presentation example of synthetic CTD data:

Substance

Resources

SubstanceDefinitionThe substance being tested
SubstanceIdentifying information about an actual batch of substance being tested (an instance)
PlanDefinitionDescribes the batch analysis protocol
ObservationDefinitionEach individual test and acceptance criteria; also used to group tests
ObservationThe results of a specific test mentioned in the ObservationDefinition
DiagnosticReportContains all results as a group and captures conclusions
Organization(not illustrated above): The company/site that performed the testing or manufacturing

Examples

eCTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic CTD data:

HTML presentation example of synthetic CTD data:

Profiles

See Artifacts Index: Batch Analysis