ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
The validation industry is entering a transformative era. Amid rising regulatory scrutiny, evolving team structures, and a strong push toward digitalization, professionals across the life sciences are being called to do more, with leaner teams and tighter timelines.
Explore June’s top reads in Pharmaceutical Engineering®—from cleanroom pressure design and AI validation to modular cell therapy manufacturing and ATMP access. Discover strategies for resilience, sustainability, and speed in pharma facility innovation.
The new ISPE GAMP® Guide: Artificial Intelligence provides a comprehensive, state-of-the-art best practice framework to efficiently and effectively achieve high-quality AI-enabled computerized systems in regulated life science areas. It bridges established GAMP concepts with...
Each year, FOYA showcases innovation, excellence, and progress in the pharmaceutical industry. The winners exemplify state-of-the-art design, cutting-edge technology, and industry best practices, continually setting new standards for what constitutes a winning project. This constant evolution keeps FOYA fresh and original, making it all the more remarkable that FOYA is celebrating its 20th...
The pharmaceutical industry is experiencing a pivotal transformation. As professionals strive to develop therapies faster, more cost-effectively, and with greater precision, Pharma 4.0™ emerges as a powerful framework for change. This evolution is not only technological—it is cultural. It challenges organizations to become more agile, data-driven, and patient-focused.
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...
As the pharmaceutical industry evolves, sustainability is becoming a key driver of operational efficiency and long-term success. From reducing carbon emissions to enhancing workforce safety, companies are aligning their practices with sustainability goals. The 2025 ISPE Annual Meeting & Expo is the ideal platform to exchange ideas and...
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.
The pharmaceutical sector is undergoing a profound transformation. As digital technologies continue to evolve, organizations are under increasing pressure to modernize legacy systems, enhance operational efficiency, and maintain compliance in a rapidly shifting regulatory landscape. The Digital Transformation track at the
Each issue of Pharmaceutical Engineering® covers a wide range of topics relevant to the pharmaceutical industry, including scientific, technological, and regulatory advancements throughout the entire...
On the closing morning of the 2025 ISPE Europe Annual Conference, Ian Jackson, an expert GMP inspector with the Medicines and Healthcare products Regulatory Agency (MHRA), presented MHRA’s Policy for the Future and Globalized Industry.
