Pharmaceutical Quality (Industry)
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Process Validation

Details about manufacturing process validation protocols and results.

Product

Resources

MedicinalProductDefinitionThe drug product (Stelbat tablets, 20mg)
IngredientThe active ingredient (stelbatalol) or the ingredients that make up the drug product
SubstanceDefinitionChemical or biological details about substance(s) associated with the ingredient
MedicationDescribes the batches that underwent testing
PlanDefinitionDescribes the process validation protocol
ObservationDefinitionEach individual test and acceptance criteria; also used to group closely related tests
ActivityDefinitionUsed to group tests such as by timings
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
Procedure(not illustrated above): Records the actual performance of a manufacturing step, so that measurements can be recorded via Observations (e.g., “hold time”, “bioburden”)
SubstanceIdentifying information about an actual batch of substance (an instance)

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

SubstanceDefinitionChemical or biological details about substance(s) associated with the ingredient
SubstanceIdentifying information about an actual batch of substance (an instance)
PlanDefinitionDescribes the process validation protocol
ObservationDefinitionEach individual test and acceptance criteria; also used to group closely related tests
ActivityDefinitionUsed to group tests such as by timings
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: Process Validation