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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?

With our pdf downloads we provide the essential information you need!

Our audit 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).

Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.

Each question with reference to the current EU GMP Guide Part I/II and the 21 CFRs 210/211/11.

For auditors and manufacturers of drugs and APIs.

NEW ++ NEW ++ NEW

 
 
GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

More than 700 questions with references to regulations for preparing and carrying out Good Distribution Practice (GDP) audits

 
 
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.

 
 
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.

 
 
 
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