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
This article is a download product! Please note the following procedure guidelines:
If you choose payment by bank transfer:
- You will receive an advance invoice.
- After payment is received an email will be sent with the download information.
If you choose payment by credit card:
- You will receive immediately after the credit card payment an email with the download information.
- The invoice will be sent by postal mail as soon as possible.
- pharmaceutical manufacturers