徐影风险理及案例分析.ppt

* Just based on EU and FDA text, we immediately see some areas where we can use a RM approach to determine amount of activity required. * * Summarize today’s key points” ” and orally quiz trainees to make sure they are clear. 1 simplified formula risk=P*S (concepts of quality risk management, risk, hazard) 2 principles 3Tools ( Ishkawa, FMEA, and PHA) 4 main elements in process ( assessment, control, communication, review,) * Summarize today’s key points” ” and orally quiz trainees to make sure they are clear. 1 simplified formula risk=P*S (concepts of quality risk management, risk, hazard) 2 principles 3Tools ( Ishkawa, FMEA, and PHA) 4 main elements in process ( assessment, control, communication, review,) * Agreement For Securing Manufacturing Control and Quality Control of Drug Substances dated 2010.03.25 Product specification dated 2010.03.25 Manufacturing Process Information dated 30 Jan 2009 Storage and Shipping information dated 30 Jan 2009 Certificate of Analysis (included within product spec) dated 30 Nov 2009 API/Excipient Manufacturers Questionnaire dated 20 April 2010 TSE Questionnaire dated 17 Feb 2011 Supplier Audit Report dated 27 May 2010 Supplier Evaluation Report dated 03 Mar 2010 Quality Performance Number of Rejects Number of Quality Issue Raised QC Test Result Summary from Sept 2006 to Nov 2010 Sampling plan references – nplan p plan etc ? * Summarize today’s key points” ” and orally quiz trainees to make sure they are clear. 1 simplified formula risk=P*S (concepts of quality risk management, risk, hazard) 2 principles 3Tools ( Ishkawa, FMEA, and PHA) 4 main elements in process ( assessment, control, communication, review,) * 日本管理大师石川馨先生发展出来的，又名石川图。是一种发现问题根本原因的方法，也可以称之为因果图 * * * * * The example that follows is for a manufacturing process. It can be adapted for many applications. The scales do not have to be as illustrated. Some people use 1 to 10 etc. * * * * * * 功能要求：合成车间A级区的功能?保护分装避免污染 潜在的失败模式：高效泄露；高效堵塞；风速达不到要求；风机坏了 失败影响：该区不