16/17 November 2021
Since the GMP regulations are sometimes not specific, concrete regulatory guidance on implementation is very helpful. In a current Warning Letter, the FDA specifies their requirements for cleaning validation. What does the FDA require?
In the Warning Letter, the medicinal product manufacturer is criticized for not having written instructions for cleaning and for not having carried out a cleaning validation. In addition to a risk assessment regarding the cleaning in the past and its effects on the product quality, the FDA also requires a comprehensive plan with
Furthermore, the FDA still requires a cleaning validation program with special emphasis on "worst-case" scenarios. As a minimum, the following should be considered as worst-case scenarios
Please see the FDA's Warning Letter issued to Syntec Pharma for more detailed information.