Pharmaceutical Quality (Industry)
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Batch/Lot Information

Details about batches of the drug product and substance, with identifiers.

Product

Resources

Medicinal Product DefinitionThe drug product (Stelbat tablets, 20mg)
MedicationIdentifying information about the actual batches of the product (instances)

Examples

CTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic quality data:

HTML rendering of synthetic quality data:

Substance

Resources

SubstanceDefinitionThe substance itself
SubstanceIdentifying information about the actual batches of the substance (instances)

Examples

CTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic quality data:

HTML rendering of synthetic quality data:

Profiles

See Artifacts Index: Domain Bundle Profiles