Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

ISPE Releases New Guidance for Pharmaceutical Change Management as Part of Product Quality Lifecycle Implementation Series

ISPE announced today that it 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.
Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences