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GMP Audits and Inspections

  • According to which principles should audits be planned?
  • What must be taken into consideration when preparing audits?
  • How are audits carried out?
  • How should audits be documented?

The following checklists are designed to support the preparation and conduct of audits and self-inspections that focus on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

GMP Audit Checklist
for Pharmaceutical and API Manufacturers

Checklist with more than 700 questions typically asked during GMP audits or inspections

GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

More than 700 questions with references to regulations for preparing and carrying out GDP audits

Preparing for the EU GMP Inspection
This handbook tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections.

Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers
This guide provides comprehensive GMP knowledge on all you need to know about chemical active substances and about audits of their manufacturers, especially in third countries.


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