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Audit Checklists

These convenient documents contain in-depth background information on planning and performing audits. The checklists navigate you through carrying out self-inspection and audits. The relevant section of the corresponding GMP or GDP guidelines appear next to each question.

Available as downloads – excerpts from the GMP Compliance Adviser

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: Now modifiable!

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

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

Pre-order now!

 
 
 
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