ISPE Publishes ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System

15 December, 2020
APQ Guide: Corrective Action & Preventive Action (CAPA) System

ISPE announced the release of its latest Guide, ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System. This 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. The Guide was developed by members of the APQ Program which evolved from the ISPE Quality Metrics Initiative, representing extensive industry engagement, collaboration with academia and other associations, and knowledge sharing with regulatory agencies.

The APQ Program recognizes that the ability to advance the maturity of quality management lies within the industry itself, and a key driver for this program is to provide a range of sustainable and practical quality management improvement strategies.  This quality management maturity program aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness within an organization.

Tami J. Frederick

Senior Director, Corporate Quality Systems and Cultural Excellence
Perrigo
Co-Lead

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System covers the key concepts of the APQ program, introduces the Assess, Aspire, Act, and Advance framework, and covers the practical application of the APQ framework to the CAPA system element by evaluating:

  • CAPA Documentation
  • Problem Identification
  • Root Cause Identification
  • Corrective and/or Preventive Actions
  • CAPA Effectiveness
  • CAPA Metrics
  • Governance, Management Oversight, and CAPA Prioritization

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