CAPA(cGMP培训系列2)

,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,Corrective Action and Preventive Action(CAPA)预防纠偏措施,GMP Training,Module 4,1,What is said in cGMP book?,Sec.211.192 Production record review.,All drug product production and control records,including those for packaging and labeling,shall be reviewed and approved by the quality control unit to determine compliance with all established,approved written procedures before a batch is released or distributed.,Any unexplained discrepancy(including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records)or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated,whether or not the batch has already been distributed.,The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.,A written record of the investigation shall be made and shall include the conclusions and followup.,2,产品记录复查,所有药品生产和控制记录，包括包装和标签记录，须按全部已制订通过的程序复查和认可。此复查和认可应在该批药品发放或销售前完成。一些不可解释性差异（包括超过在主要生产和控制记录中制订的最大或最小百分数的理论产量的百分数）或一批或任何一个成份不符合其规格中任一项，,则应作彻底调查,，不管这批药品是否已销售。这种调查应提高扩展到该同一药品的其他批号和与此具体的不合格或差异相联系的其它药品。,调查应写成文字记录，包括结论和继续跟踪。,3,What are the symptoms of an effective CAPA system?好的预防纠偏系统有 那些特征？,A reduction in quality issues,A reduction in the severity of issues,More preventive actions over time,More consistent products/processes,Improved customer satisfaction,Better business results,4,What are the symptoms of a less than effective CAPA system?,不好的预防纠偏系统有 那些特征？,Recurring issues,Inability to“manage”the many sources of quality data to understand early trends and issues,More reaction than prevention,Resources($)are spent on“handling”failure rather than learning from it and preventing“more of the same”,Field issues,5,What are FDA enforcements on CAPA?,FDA,对不称职的,CAPA,有何措施,Ineffective CAPA system is one of the most commonly found problems in FDA inspection report and warning letters.,Nonconformities are cited during inspection,and corrective action plan required.,Warning Letter more serious,available to the public,Fines,stop product shipment,6,Is your CAPA system effective?你们的CAPA系统如何？,Written procedures?Example,CAPA team/Investigation committee?,有无文件？,预防纠偏团队,/,调查委员会,Results?,Do you have a log of CAPA?Example,Do you have a closed CAPA case?Example,Do you have an active CAPA case?Example,7,Elements of an Effective CAPA Process,有效,CAPA,流程的组分,Documented procedure(s),Defined CAPA inputs,Risk assessment and prioritization,Investigation disciplines,Verification/validation,Well defined action plan,Disseminate information,Documentation rules,Effectiveness checks,Complete?Effective?Timely,Defined criteria for Management Review,Management escalation,Metrics-ability to monitor progress,8,CAPA Simplified简单流程,Define the Problem,Initiate CAPA,Investigate Cause,Solution,(Action Plan),Verify/Validate,Conduct,Effectiveness Check,Implement,Close CAPA,9,10,11,Where can CAPA come from?CAPA可以从哪里产生？,Discrepancies,Unexplainable deviations,Audit Results,Recurring audit observations,internal audits and external audits,Quality Records,Periodic review,Process control,Testing results,trends,etc,Post Market data,Frequency and occurrence as expected?,Service Records,Complaints,Returned Products,12,Problem Definition描述问题,State the problem in measurable terms,how often,how much,when,and where,Emphasize the effects(risk),safety,death,injury,rework,cost,etc.,The problem statement is the difference between what,is,and what,should be,Focus on,facts,not emotions,what,is wrong,not,why,its wrong,Avoid,negative descriptors,inflammatory statements,words that are broad and do not describe the conditions or behavior such as careless,complacency,neglect,oversight,13,Is/Is Not Diagram是非表,WHAT,WHEN,WHERE,EXTENT,IS,IS,NOT,14,15,Investigation Methods,方法,Define method of investigation,Include quality tools used,Cause and Effect,6 Ms,5 Whys,etc.,Document,Dates of investigation,Data reviewed(data sources,records,dates),Corrections or Containment measures,Results:Statement of Cause,16,Different Causes不同原因,Presumptive Cause,可能原因,apparent during early investigation,hypotheses that may explain the effect but needs validation,Contributing Cause,侧面原因,secondary and possible causes,Root Cause,根本原因,primary reason for the problem which if corrected will prevent recurrence,17,Method 1-Five Whys五个为什么？,A questions-asking method used to explore root cause of a problem.,Example:,My car will not start.(the problem),Why?,-The battery is dead.(first why),Why?,-The alternator is not functioning.(second why),Why?,-The alternator belt has broken.(third why),Why?,-The alternator belt was well beyond its useful service life and has never been replaced.(fourth why),Why?,-I have not been maintaining my car according to the recommended service schedule.(fifth why,a root cause),