Not a Member?

Gain industry knowledge, learn best practices, network with peers, and advance your career with the largest not-for-profit association in the pharmaceutical industry.

Join now and get Member Pricing on your purchase!

Learn More
* ISPE does not pay customs or duties on international shipping.
Shipping and Return Policy
Publication Order Form

Guidance Document License Agreement

The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser.

Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.

Membership discounts are available only to current members and are intended for individual use of the guides, not for resale.

View the Guidance Document License Agreement   



PQLI Guide: Part 3 - Change Mgmt Sys Download - USD
PQLI Guide: Part 3 - Change Mgmt Sys Download - USD
PQLI Guide: Part 3 - Change Management System
Discounted member price: 105.00
You could save 74.1%
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.

Member Price: $ 105.00
Non Member Price: $ 405.00