Other than the Identity testing which must be performed after packaging, as per Interpretation 1 under
C.02.019 Finished Product Testing, there is no specific requirement to perform the other tests after packaging
including potency. In such cases, the manufacturing process must be validated to demonstrate that the
packaging / filling operation does not alter the quality of the product (including potency). These validation
data must also demonstrate that the homogeneity of a product is maintained by appropriate means throughout
the entire filling process for dosage forms such as lotion, creams or other suspensions. For parenteral,
ophthalmic, and other sterile products, at least identity and sterility testing must be performed on the product
in the immediate final container.
For the requirement to perform the identity testing after packaging, the unique identifier principle can be used
as long as the chemical / biological identity test has been performed after the unique identifier is applied to
the product.
