Sampling the gloves of operators is "unacceptable" as a means of detecting contaminants in an environmental monitoring program. The FDA tells Sanofi-Aventis Deutschland chairman Martin Siewert in Warning Letter 320-11-09 that the program should capture "meaningful data" and act as an early warning system to sterility breaches.
Sanofi's procedure involved left and right hand glove sampling on alternate days.
The agency also found fault with the drugmaker's aseptic processing methods and provided direction on its expectations and a bit of tutorial. "You should be able to demonstrate unidirectional airflow and sweeping action over and away from the product under dynamic conditions," the letter says. Proper design prevents turbulence and stagnant air. "It is crucial that airflow patterns are evaluated for turbulence that can act as a channel for contamination."
The observations stem from a September 2010 inspection of the plant in Frankfurt. The company answered the observations in October 2010 and January 2011 responses, but they fell short. "We continue to have concerns related to your firm's compliance with CGMP," the letter says.
- here's Warning Letter 320-11-09