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ISPE Releases New Guidance for Pharmaceutical Change Management

June 5, 2012

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 3 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,” said 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 their change management practices, this Guide provides the tools they need to reach their goal.”

The PQLI Guide on Change Management outlines potential product lifecycle approaches to the change management system of a Pharmaceutical Quality System (PQS). It provides clear guidance on achieving compliant and consistent change management systems and describes how to implement compliant change management systems within a PQS. PQLI 3 – Change Management can be used in conjunction with the first two PQLI Guides as part of a larger Quality by Design approach, or as a stand-alone change management manual.

The ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) 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.