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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).

GDP Audit Questionnaire
for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices

NEW: now also for active substances and modifiable!

More than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of Good Distribution Practice (GDP) audits

Your perfect working tool: compact and practice-oriented!

NEW ++ NEW ++ NEW

 
 
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.
Your perfekt working tool: compact and practice-oriented!

NEW: Now modifiable!

 
 
 
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