• Conventional process validation typically entails a certain number of consecutive successful manufacturing batches at a commercial scale prior to submissions of major regulatory packages - such as BLA’s. This approach has been and may still be practiced in many regulatory jurisdictions. Nevertheless, a more wholistic and integrated strategy has emerged over the past decades, calling for more lifecycle-oriented considerations. In essence, process performance qualification (PPQ) is now established on a more continuous basis over the entire product life cycle, hence continuous process verification (CPV). 

• The conventional process validation approach is still appropriate but only as a subset of the overall process performance qualification effort.  PPQ in conjunction with CPV encompasses the entirety of process performance metrics: building on the foundation of Quality by Design (QbD), emphasizing risk-based control strategies, effectively managing lifecycle knowledge, planning for continuous improvements, etc. They are now viewed as guiding principles for ensuring consistent manufacturing process performances.

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