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 3 of the PQLI series, provides practical, real-world strategies that companies can use to implement the change-management recommendations of ICH Q10. 

The PQLI guide on change management outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system (PQS). It provides guidance on achieving compliant and consistent change-management systems and describes how to implement compliant change-management systems within a PQS. 

 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.

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The new guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.