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since Eric consulting presents your GMP minute with Kevin wall this episode was co-authored with Eric Sexton today we will discuss the FDA validation guidance and I CH what should you know process validation can be defined generally as a series of activities taking place over the life cycle of the product the validation exercise establishes scientific evidence that a process is capable of consistently delivering a quality product after 24 years the FDA updated its process validation guidance in 2011 the changes were consistent with trends in place within the pharmaceutical industry the views changed from validation being a point in time event to being applicable over the product life cycle the life cycle approach to drug product management is laid down in IC h q10 pharmaceutical Quality Systems be sure to subscribe to our Channel and click the notification bell so you dont miss a GMP minute the FDA describes process validation as taking place in three stages process design process qua