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.
|SKU||Pre Approval Inspection - Free GMP SOP|
What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
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
- 21 Part 11 Compliance Plan - GMP Validation Master Plan (VMP)Regular Price $280.00 Today $219.00+ 19% german VAT when applicable
- PAI Protocol For Drug Products - GMP ChecklistRegular Price $240.00 Today $209.00+ 19% german VAT when applicable
- PAI protocol for API - GMP ChecklistRegular Price $230.00 Today $198.00+ 19% german VAT when applicable
- 21-CFR 820 Quality systems GMP ChecklistRegular Price $260.00 Today $219.00+ 19% german VAT when applicable