Pre Approval Inspection - PAI - Free GMP SOP
- Reasons for PAI
- Pre-Inspection Activities
- During the Inspection
- The Exit Meeting
- Post-Inspection Activities
Reasons for PAI - This section describes the various reasons for Pre Approval Inspections and the main US and EU registration applications.
Pre-Inspection Activities - This section will help you to understand why the Pre Inspection Activities will be the crucial factor to successfully pass a Pre Approval Inspection.
During the Inspection - This section shows how closely success or failure is linked with the skills and capabilities of the personnel fronted to an inspector and the importance of a perfect backroom organization.
The Exit Meeting - This section will give a brief description of a standard PAI exit meeting held on the last day including some advise on correct attitude and reaction.
Post-Inspection Activities - This section provides guidance on how to react to Inspector’s citation including time proposal and some further recommendations for the post inspection activities.
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Very helpfull Free GMP SOP!Pre Approval Inspection - PAI - Free GMP SOP onI could prepare the FDA Audit perfectly with this free SOP - surely written by experts