Thứ Hai, 11 tháng 1, 2021

Hướng dẫn của ISPE - Hệ thống CAPA (ISPE APQ guide - Corrective Action and Preventive Action System)

 


What is the current state of your organization’s Corrective Action and Preventive Action (CAPA) System? Is it robust, consistent, and efficient? The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating:
  • CAPA Documentation
  • Problem Identification
  • Root Cause Identification
  • Corrective and/or Preventive Actions
  • CAPA Effectiveness
  • CAPA Metrics
  • Governance, Management Oversight, and CAPA Prioritization.
The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in the planned four-part series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. The Guide Series is part of ISPE’s newest initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive program for assessing and improving an organization’s quality management maturity.


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