ISPE releases guide to corrective and preventive action

Published: 15-Dec-2020

The ISPE is a not-for-profit association which produces scientific, technical, and regulatory advice across the entire pharmaceutical lifecycle

The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest APQ guide: Corrective Action and Preventive Action (CAPA) System. This is the first in a planned four-part series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance.

The series is part of ISPE’s advancing pharmaceutical quality (APQ) initiative, a program for assessing and improving an organisation’s quality management maturity. The guide was developed by members of the APQ Program which evolved from the ISPE quality metrics Initiative, representing 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,” said Tami Frederick, Global Director, Quality Systems, Perrigo, Guide co-lead. “This quality management maturity program aims to identify good practices and good behaviours which support the continual improvement of quality management effectiveness within an organisation.”

The APQ guide: Corrective Action and Preventive Action 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, and several other topics.

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