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ISPE Releases New Book in Pharmaceutical Quality Life Cycle Series

Change Management System as a Key Element of a Pharmaceutical Quality System

Published: Wednesday, June 6, 2012 - 10:47

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) has released the latest volume in the Product Quality Lifecycle Implementation (PQLI) series, Change Management System as a Key Element of a Pharmaceutical Quality System. The guide, which is part three of the PQLI series, provides practical, real-world strategies that companies can use to implement the change management recommendations of ICH Q10. It is the only change management guide written expressly for the pharmaceutical industry.

“Good change management is an important part of any business, but for the pharmaceutical industry, there are special considerations that must be kept in mind,” says guide author Rob Hughes. “Whether a company needs help translating the holistic approach described in Q10 into an actionable plan or simply wants to update and improve its change management practices, this guide provides the tools they need to reach their goal.”

The PQLI guide on change management outlines potential product life cycle approaches to the change management system of a pharmaceutical quality system. It provides clear guidance on achieving compliant and consistent change management systems, and describes how to implement compliant change management systems within a pharmaceutical quality system. This third guide of the PQLI series can be used in conjunction with the first two guides as part of a larger quality-by-design approach, or as a stand-alone change management manual.

The PQLI Guide: Part 3—Change Management System as a Key Element of a Pharmaceutical Quality System is available for purchase from ISPE at www.ISPE.org/pqli-guides/change-management-system.


About The Author

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The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.