Pre Approval Inspection - PAI - Free GMP SOP

  • Reasons for PAI
  • Pre-Inspection Activities
  • During the Inspection 
  • The Exit Meeting
  • Post-Inspection Activities

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Description

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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More Information
SKU Pre Approval Inspection - Free GMP SOP

FDA-EMA

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