InTouch
The new ISPE Guide: Quality Risk Management provides practical direction on applying QRM principles across the full product life cycle.
Gabriela Kantor
ISPE
Technical Editor
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ISPE’s 2026 AI in Life Sciences Summit—Powered by GAMP® brought together a diverse group of regulators and pharmaceutical and technology professionals to address the growing opportunities and challenges for applying artificial intelligence (AI) in the pharmaceutical industry and to explore the rapidly evolving role of AI in regulated environments.
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In today’s rapidly evolving pharmaceutical landscape, ensuring product quality, patient safety, and reliable supply has never been more critical, or more complex. As regulatory expectations and supply challenges continue to rise, the ISPE Guide: Quality...
iSpeak Blog
In today’s pharmaceutical manufacturing landscape, ensuring product quality and patient safety while accelerating time to market has never been more critical. This recent Addendum provides further clarity, practical insights, and implementation recommendations to help organizations optimize their C&Q delivery processes.
InTouch
In today’s life sciences landscape, process control systems (PCSs) have become the backbone of modern manufacturing. These computerized systems monitor and influence physical processes in real time, ensuring that safe, high-quality products reach patients around the world. Because PCSs often interact directly with equipment, facilities, and materials, they carry significant responsibility in...
InTouch
The new ISPE Good Practice Guide: Continuous Manufacturing of Biological Products shows how continuous biomanufacturing (CBM) becomes compelling when it delivers reliable, scalable, decision-grade data that tie directly to financial outcomes and operational agility. It also provides regulatory considerations and life-cycle management concepts for the integration of future technologies that are...