Since its original publication in 2009, the ISPE Good Practice Guide: Heating, Ventilation and Air Conditioning has been helping engineers design heating, ventilation, and air conditioning (HVAC) systems that meet regulatory compliance while maintaining product safety, worker safety, and comfort.
At the 2024 Facility of the Year Award (FOYA) Celebratory Banquet, ISPE announced the 2024 overall FOYA winner: Eli Lilly Kinsale Limited’s IE2b project. In addition to winning the overall award, Eli Lilly’s IE2b project was recognized as the 2024 Innovation category winner for its innovation in synthetic peptide manufacturing.
Mark Cherry is the IT Compliance Director and GXP subject matter expert at AstraZeneca. A chartered engineer, he has been with AstraZeneca for 22 years and was previously with GlaxoSmithKline in a variety of computer compliance and engineering roles. He has been a member of ISPE since 1999.
In addition to serving on the GAMP Europe Community of Practice (CoP) as Chair, he led the team...
The new ISPE International Board of Directors was introduced, the gavel was passed to a new Chair, and Honor Award Winners were announced on 15 October 2024 during the 2024 ISPE Membership Meeting and Awards Lunch in Orlando, US, during the 2024 ISPE Annual Meeting & Expo.
This special anniversary article addresses the history and milestones that define the GAMP Community of Practice (CoP). In celebration of the 25th anniversary of the creation of GAMP Americas, we reflect on the vital role GAMP Americas has played in that journey. We commemorate key accomplishments of its members, share recent activities, and look ahead to the future of GAMP Americas.
ISPE GAMP® 5: A Risk Based Approach to Compliant GxP Computerized Systems (Second Edition),1
This article describes a practical and pragmatic approach to the management of computerized system life cycle and information technology (IT) process records. The objective is to effectively achieve and maintain compliant GxP-regulated systems that are fit for intended use, and to support patient safety, product quality, and data integrity.
Mike Martin assumed his new role as President and CEO of ISPE and the ISPE Foundation in January.
In the ever-evolving landscape of the pharmaceutical industry, the Women in Pharma® Steering Committee has taken significant steps to foster collaboration, share insights, and strengthen community engagement among the ISPE community. Over the past year, our commitment to these initiatives has opened doors for Women in Pharma Affiliate and Chapter leaders to connect, exchange best practices,...
Mahatma Gandhi, Winston Churchill, and Golda Meir were some of history’s greatest leaders. One thing they all had in common was that they were leaders of incredible personal character. General Norman Schwarzkopf said, “Leadership is a potent combination of strategy and character. But if you must be without one, be without the strategy.”
