This questionnaire contains 650 questions typically asked during inspections, arranged by subject-matter. The correct section of the corresponding guidelines is quoted next to each question. This way the background of the question and possible answers can be easily researched in the original guidelines and laws. The information sources include the 21 CFR 210/211/11 and the EU-GMP-Guide Parts I and II. Use the list for preparation and enforcement of your next audit:

The checklist GMP-Inspections is great for both sides:
- Get prepared for an audit to come
(what questions do I need to expect, what should I prepare for, etc.)
- For your own inspection (internally and externally) and documentation

auditors, manufacturers and suppliers

Dr. Christine Oechslein

also available in German:
Checkliste GMP-Inspektionen