用于完整性保证的 SUS 的设计、控制和监测.pdf

1、Design,Control&Monitoring of SUS for Integrity Assurance,Volume 2P.Evrard,C.Masy,S.Patterson,C.Zhang and the full BPSA SUS Integrity Assurance CommitteeJuly 11,2023AGENDA Why a new document on integrity of SUS?What will you find in this document?What did we learn and what are the next steps?INTRODUC

2、TION BPSA Tech Guide-2017-Volume 1 Principles Once upon a time in February 2021 Why a Volume 2?Case studies UpdatesTHE SUS INTEGRITY ASSURANCE COMMITTEECommittee MembersEmily Alkandry,Saint-GobainSebastien Barry,SanofiRichard Bhella,CytivaMonica Cardona,Millipore SigmaJoussef Chaaban,CytivaKatie Chu

3、rch,Watson MarlowRafael Diana,CytivaRoger Hendrick,DupontNicole Hunter,Watson MarlowYves Lambeens,CytivaCharlotte Masy,GSK VaccinesNathalie Pathier,SartoriusScott Patterson,ILC DoverMark Petrich,Merck&Co.,Inc.Kevin Pickup,Thermo Fischer ScientificElke Roelandt,PfizerChanghong Zhang,Sanofi PasteurBPS

4、A FacilitatorJeanette McCoolAuthors Currently Out of the CommitteeMichael Avraam(ChargePoint Technology)Marc Hogreve,Sartorius*Alain Vanhecke,Cytiva*Patrick Evrard,Cytiva-Board Sponsor and Committee Chair*sabbatical leaveCONTENT Case study:design,qualification and validation of a SUSfor a critical a

5、pplication using QbD principles Cases studies:integrity issues with various components Updates on integrity testing technologies Handling practices and training Industry Interest Groups initiatives and regulatory landscape Case studies:specific applicationsDESIGN,QUALIFICATION AND VALIDATION OF A SU

6、S FOR A CRITICAL APPLICATIONAssessment of Criticality related to integrity Patient safety risk:Breach sterility Business risk:Massive product loss from leakDS PumpFilling station0.2 um filter train200L Sterile DS bagGrade A Isolator,Filling10L Surge bag,DP DESIGN,QUALIFICATION AND VALIDATION OF A SU