MDR Article 83.4和CAPA直接有关. “If, in the course of the post-market surveillance, a need for preventive orcorrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Wh...
ISPE APQ指南-纠正措施和预防措施(CAPA)系统Corrective Action and Preventive Action(CAPA) System-2020(中文版) 下载积分: 1000 内容提示: 文档格式:PDF | 页数:136 | 浏览次数:138 | 上传日期:2022-11-29 15:47:00 | 文档星级: 阅读了该文档的用户还阅读了这些文档 7 p. HJ 1410.13-2025 水生...
CAPA 纠正预防行动Corrective and Preventive Action精选.pdf,Pharmaceutical Services Corporation 美国医 服务有限公司 Corrective and Preventive Action 纠正预防行动 PDF 文件使用 pdfFactory Pro 试用版本创建 Definition 定义 CORRECTIVE ACTION Putting out a fire
QAdvancingPharmaceuticalQualityISPEQualityManagementMatur1tyProgramGUIDE:CorrectiveActionandPreventiveActionCAPASystem
Action PDF文件使用"pdfFactoryPro"试用版本创建.fineprint.cn 2 •CORRECTIVEACTION–Puttingoutafireafterithas started. 纠正行动:着火后进行灭火 •PREVENTIVEACTION–Observingconditionsthatmay startafireandremovingthemfromthesystem. 预防行动:观察可能引起火的条件,并从系统中除去它们 •CorrectiveAction(ICHQ10)-...
This is not a comprehensive guide on corrective action and preventive action (CAPA) for a specific industry like a medical device, pharma, etc., but a simplified overview of CAPA, with an example of various industries. Always follow the standards applicable to you and your company!
7-纠正措施与预防措施CAPA(英)
CorrectiveandPreventiveAction(CAPA)isasystemof: Qualityproceduresrequiredtoeliminatethecausesof anexistingnonconformityand topreventrecurrenceof: ononconformingproduct, ononconformingprocesses,and ootherqualityproblems. Qualityshouldbebuiltintotheproduct,andtestingalone ...
Verification of corrective and preventive actions:Implemented. Ok, we are now at the last step of the CAPA for the malfunctioning implantable pacemaker (verification of corrective/preventive actions). For example, you have found out that a break in the wire insulation has led to the EC failure....
CAPA Pharmaceutical Services Corporation 美国医药服务有限公司 Corrective and Preventive Action 纠正预防行动 PDF 文件使用 "pdfFactory Pro" 试用版本创建www.fineprint.cn