Remembering Ken Chapman: Points to Consider for 3-Stage PV

摘要

This paper continues a presentation on the same topic given at IVT Validation Week Europe held in Brussels in Mar 2018. It revisits the pioneering efforts of the late Ken Chapman in validation, and highlights the many synergies that exist between his insights and the requirements of 21st Century process validation (PV). It is written in the style of “a day in the life of a process variable.” The FDA 3-Stage PV lifecycle approach can be satisfied by the application of rudimentary principles originally attributed to Ken Chapman.