|Published: June 2012
Table of Contents ( 180 KB)
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The ISPE PQLI Guide: Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System, is the only change management guide written expressly for the pharmaceutical industry. It provides practical, real-world strategies for implementing the change management recommendations of ICH Q10. The Guide contains information to help translate the holistic approach described in Q10 into an actionable plan and can help companies update and improve their change management practices.
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 Part 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.