Whitepaper: Improved aseptic processes and monitoring to reduce FDA 483s
In recent years, the FDA response to companies with insufficient proof of control over their production has become more aggressive…
Topics related to environmental monitoring programs are included in the most common reasons 483s are issued. By becoming aware of the regulations and reasoning backing 483 distribution, pharmaceutical companies prepare against making mistakes.
The FDA Committee has increased warning letter distribution dramatically in recent years. Notably, there has been a significant increase in the number of warning letters referring to “data integrity” and “sterility assurance”, in relation to environmental monitoring (EM). The increase is attributed to a dramatic change in the FDA regulator approach to infraction handling.
The FDA fully expects that product bioburden be assessed and evaluated. Control of Microbiological Contamination states that the “appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed”. Such procedures should include validation of all aseptic and sterilization processes.
The whitepaper is restricted - login or subscribe free to access
Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.
Why subscribe? Join our growing community of thousands of industry professionals and gain access to:
- bi-monthly issues in print and/or digital format
- case studies, whitepapers, webinars and industry-leading content
- breaking news and features
- our extensive online archive of thousands of articles and years of past issues
- ...And it's all free!
Related content from this organisation
- Applying quality risk management to develop an isolator filling line
- Whitepaper: The importance of data integrity in current regulation
- One stop to meet contamination monitoring regulations
- Holistic approach to data management for pharmaceutical manufacturers
- Environmental Monitoring In-Depth Focus 2018