The Pre-Approval Inspection Program gives general inspection guidance for investigators, with emphasis on oral solid dosage forms.  However, it provides little direction for the inspection of sterile products.  There have been many questions raised during our inspections regarding the interpretation and evaluation of GMP issues such as process validation, that are applicable to sterile products.  There have also been a number of questions raised regarding inspectional coverage in the pre-approval and post-approval inspection.  That is what systems and processes have to be qualified and/or validated at the time of the pre-approval inspection.



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