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...
CAPA,英文Corrective Action and Preventive Action首字母的缩写,中文意思是纠正措施和预防措施。CAPA英文的意思表达是准确的,但中文词在实际应用时,很多时候可能是为了方便,会说成纠正和预防措施,事实上我国的GMP条款也是这么写的。我特意查了欧盟GMP的原文,他使用的表达是“Corrective and Preventive Actions”,所以我们...
corrective actions and preventive actions are incorporated into the iterative design and development process. 探讨产品或工艺的可变 性。CAPA方法论很有 用,可在反复设计和研 发过程中应用纠正行动 和预防行动。 CAPA can be used as an effective system for feedback, feedforward and continual...
QAdvancingPharmaceuticalQualityISPEQualityManagementMatur1tyProgramGUIDE:CorrectiveActionandPreventiveActionCAPASystem
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14.Corrective And Preventive Action (CAPA)问题补充:匿名 2013-05-23 12:21:38 14.Corrective和预防措施( CAPA ) 匿名 2013-05-23 12:23:18 14.纠正和预防措施(负荷) 匿名 2013-05-23 12:24:58 14.Corrective和预防措施 (CAPA) 匿名 2013-05-23 12:26:38 14.纠正和预防措施 (CAPA) ...
CAPA 是纠正措施和预防措施 (CAPA) 的缩写。MDR 的第2条对 CAPA 的定义进行了阐述。“上市后监督”指的是制造商与其他经济运营商合作，系统地收集和审查他们投放市场的设备所获得的经验，以便主动识别任何需要立即采取必要的纠正或预防措施的情况。“纠正措施”是指为消除潜在或实际的不合格或其他不良...
What is CAPA process? This process helps collect and analyze relevant product-related information; identify and investigate product and quality problems; and trigger appropriate and effective corrective and/or preventive actions to prevent problem recurrence. Before the digitally connected enterprise, the...
CAPA 纠正预防行动Corrective and Preventive Action,CAPA 纠正预防行动Corrective and Preventive Action,CAPA,and,纠正预防,AND