Yes. These operations are part of manufacturing. For drugs that are packaged into trays or kits and the
resulting package is sterilized prior to being marketed, data should be available to demonstrate that the
sterilization process does not adversely affect the physical and chemical properties of the drug. The testing
should be sensitive enough to detect any potential chemical reactions and/or degradation, and the test results
should be compared with test values obtained prior to sterilization.
