The FDA confirmed in its latest guidelines for process validation that it wants to go to a risk-based approach. This is consistent with the direction of previoud drafts. The biggest change - welcomed by industry generally - is the removal of any requirements to perform viral clearance and impurity removal studies under GMP conditions. These now only need to be done under quality unit oversight. This makes sense for companies not wanting to expose their manufacturing site to dangers durign development of these processes.
The new guidance is consistent with ICH Q5A and Q10 and the European CPMP/BWP/268/95. It confirms that process validation shoudl be looked at as a lifecycle activity rather than a one-time event. The FDA says the guidance "encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle..."
I can say that we've incorporated more and more risk-based anaylses into developing our R&D schemes and have found these exercises in proactively identifying potential hurdles and using the information in study design. It just makes sense to be aware of risks when putting studies together (process validation or otherwise).
Posted by Bruce Lehr Feb 25th 2011.