This questionnaire contains 650 questions typically asked during GMP inspections, arranged by subject-matter.
The correct section of the corresponding GMP 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 GMP audits:
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 GMP inspection (internally and externally) and documentation
The correct section of the corresponding GMP 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 GMP audits:
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 GMP inspection (internally and externally) and documentation
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- auditors
- pharmaceutical manufacturers
- suppliers
- pharmaceutical manufacturers
- suppliers
This document is an excerpt from the GMP MANUAL.
