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.
Senior Director, Corporate Quality Systems & 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
