GAMP Guide: Artificial Intelligence
Published: July 2025 Pages: 290 Table of Contents Special Pricing for Emerging Economies Technological innovations in Artificial Intelligence (AI) provide new opportunities for the life sciences, and offer new ways to approach challenges in GxP
iSpeak Blog

The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace, while lowering drug costs, enhancing quality, and maintaining safety and a robust supply chain. Validation 4.0 ensures that validation processes are not a bottleneck but a strategic enabler of innovation, quality, and compliance by embracing artificial intelligence (AI), Internet of Things...

iSpeak Blog

The pharmaceutical industry is no stranger to innovation. From pioneering drug development to advanced manufacturing processes, it thrives on new ideas. But when it comes to construction, particularly the delivery of critical infrastructure such as laboratories, cleanrooms, and research facilities, many companies in the sector still rely on traditional building methods.

Audio file
2025-07-01T08:57:34

In part one of our two-part series on the future of ATMPs, David Phasey, Business Development Director at 3P Innovation, joins the podcast to discuss the drivers of the high cost-of-goods (COGs) for ATMPs and how automation can help reduce these COGs

iSpeak Blog
As I approach the six-month mark in my role as President and CEO of ISPE, I’ve been inspired by the energy and commitment of our global community. One of the most meaningful experiences so far was from a recent visit to Shanghai, China, for the 2025 ISPE China Conference hosted by the ISPE China Office—an event that marked the official restart of ISPE’s presence in China.
Affiliates/Chapters News & Press Releases
19 June 2025
SaaS validation proved to be a topic of a lot of interest for all attendees joining ISPE GAMP CoP Benelux event on June 19th, hosted by UCB, Anderlecht. The event was opened by Natasja Bastiaens, ISPE GAMP CoP Benelux Chair and the event sponsor UCB...
Good Practice Guide: Validation 4.0
The Validation 4.0 Guide provides a comprehensive approach to ensuring product quality and patient safety throughout a pharmaceutical product's lifecycle. A Holistic Control Strategy (HCS) in this context means moving beyond traditional, static, upfront and localized validation controls to a dynamic, data-driven, and continuous approach to managing risks and quality along the broader value chain.
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Address: BTEC - NC State Centennial Campus
Golden LEAF Biomanufacturing Training and Education Center
850 Oval Drive, Raleigh, NC 27606
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