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If you’d like to be regularly informed on the latest developments in Good Manufacturing Practices

 

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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.

 
 
GMP Inspections in Europe: Proven Strategies on How to Prepare
An interactive workshop for inspection preparation by Thomas Peither and Bernhard Gotter (BAYER). You learn how to prepare and how to run a state-of-the-art GMP inspection.

 
 
 
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