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Whitepaper: Improved aseptic processes and monitoring to reduce FDA 483s

Posted: 13 December 2017 | | No comments yet

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.


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