Ten steps to ensure a successful preNDA approval inspection.

To say that the FDA preapproval inspection program has generated much interest is an understatement. There have been multiple Commissioner Exchange Meetings at various locations throughout the United States and several multi-day workshops sponsored by the industry to help clarify how to prepare for this inspection. In order to establish a baseline of understanding, we will look, briefly, at the agency expectations. We will then look at the general trends that we have observed either directly from the preapproval inspections we have experienced or indirectly from 483 observations from other preapproval inspections. Finally, the ten steps which are used at Eli Lilly and Company to prepare for preapproval inspections will be presented.