风险评估在qa审查中的运用.pdfVIP

Risk based assessment applied to Risk based assessment applied to QA GLP audits QA GLP audits Alain Piton Alain Piton Galderma RD, Sophia-Antipolis, France Galderma RD, Sophia-Antipolis, France alain.piton@ alain.piton@ OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008 OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008 RISK BASED ASSESSMENT RISK BASED ASSESSMENT FOR GLP AUDITS FOR GLP AUDITS INTRODUCTION Since the origin of GLP the standard plan for QA inspections is based upon the concept of study and critical phases. The concept of facility-based and process-based inspections emerges since a decade. The “default standard” in the industry is still driven by the studies and the idea that facility-based and process-based should be performed quarterly. The concept of processes, brought by the ISO standards, and the business need of optimizing the use of resources lead us toward a process based inspection concept, driven by the risks associated to the processes This presentation is aimed to suggest to what extent this approach is GLP compatible OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008 OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008 GLP inspections GLP inspections Authorities requirements Authorities requirements • FDA: Inspect each non clinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date