Interview with Frank Panofen, Life Science Marketing Manager at Particle Measuring Systems How do we solve cleanroom contamination control issues when face-to-face discussions and in-person visits are not an option? In this interview, Dr. Frank Panofen of Particle Measuring Systems (PMS) explains how PMS advisors tackled travel restrictions and the…
The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in all aspects of sterile product manufacturing. Here we highlight requirements related to Quality…
How to define a Contamination Control Strategy (CCS) in 3 steps.
Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy. This blog series goes into depth on both topics.
How do the guidelines define a Contamination Control Strategy (CCS)?
Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy. This blog series goes into depth on both topics.
