Development and use of a risk based approach to system commissioning and qualification – SAT and FAT Test Capitalization, Co-presenter: Cristina Testoni

Paolo Michele Leani

Application of Risk Management for Commissioning & Qualification of Pharmaceutical Water System is presented. Starting from the risk management principles as per ICH Q9, making also reference to ISPE Guide “Applied Risk Management for Commissioning and Qualification –2011” , the authors will give a possible interpretation and execution of the Risk management methodology to “capitalize” the Factory Acceptance Tests (FATs) executed at Supplier Factory for different Pharmaceutical Water Systems Unit (ME Stills, PSGs, RO-EDI Units) in view of further Site Acceptance Tests (SATs) to be executed at final user site. The goal is achievable with deep participation of customer Quality Unit in the FAT/SAT process as well as customer S.O.Ps to support Risk Management Process