The International Society for Pharmaceutical Engineering (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,” said Tami Frederick, Global Director, Quality Systems, Perrigo, Guide co-lead. “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.”

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

Purchase the ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System online, available at ISPE.org/Publications/Guidance-Documents, among ISPE’s other detailed education resources on a variety of industry topics.

About ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 Members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA