ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
The ISPE D/A/CH Affiliate, encompassing Germany, Austria, and Switzerland, represents a diverse and highly engaged community within one of Europe’s key pharmaceutical regions. The Affiliate was recognized as the largest of ISPE’s 40+ Affiliates and Chapters at the 2026 Facilities of the Future Conference in February, underscoring both the scale of the regional industry and the strength of its...
The 2026 ISPE International Board of Directors Election provides members with the opportunity to help shape the future of the Society by voting for representatives to fill open seats on the International Board. The Board plays a critical role in establishing ISPE’s vision and mission, setting strategic priorities, and ensuring that operations align with ISPE policies, best practices, and...
The pharmaceutical industry has never lacked ambition. Across the globe, scientific discovery continues to move at extraordinary speed. New modalities, advanced therapies, precision approaches, digital platforms, automation, artificial intelligence, and novel manufacturing technologies are expanding what may be possible.
Batch disposition remains one of the most important quality decisions in pharmaceutical manufacturing. Before a product can reach a patient, reviewers must confirm that the batch was manufactured, tested, documented, serialized, and controlled according to approved procedures and regulatory expectations. This work protects patients, preserves product quality, and ensures compliance. Yet in...
The 2026 ISPE International Board of Directors Election provides members with the opportunity to help shape the future of the Society by voting for representatives to fill open seats on the International Board. The Board plays a critical role in establishing ISPE’s vision and mission, setting strategic priorities, and ensuring that operations align with ISPE policies, best practices, and...
After three years of volunteer-driven effort, the ISPE Greece and Cyprus Affiliate officially joins the global ISPE community, creating new opportunities for knowledge sharing, professional development, and industry collaboration across the region.
When you ask a computer system validation (or assurance) professional to describe their job, they describe their projects. A system implementation, a multi-phase, multi-regional program, or a validation lifecycle for a specific application. That framing is understandable; the guidance documents and quality procedures are organized the same way. Validation of computerized GxP systems is...
The 2026 ISPE International Board of Directors Election provides members with the opportunity to help shape the future of the Society by voting for representatives to fill open seats on the International Board. The Board plays a critical role in establishing ISPE’s vision and mission, setting strategic priorities, and ensuring that operations align with ISPE policies, best practices, and...
How ISA-95 system layering, NTP synchronization, and interface validation scope determine whether a plant's data holds up under regulatory scrutiny.
Bioprocess scale-up rarely follows the smooth saturation curve that yield models implicitly assume. As a representative illustration of the pattern, a pilot run can deliver 92 percent line yield, while the commercial-scale confirmation run that should deliver roughly 89 delivers 71. Those figures are illustrative of the regime-transition signature rather than a single named plant’s record, but...
The 2026 ISPE International Board of Directors Election provides members with the opportunity to help shape the future of the Society by voting for representatives to fill open seats on the International Board. The Board plays a critical role in establishing ISPE’s vision and mission, setting strategic priorities, and ensuring that operations align with ISPE policies, best practices, and...
The pharmaceutical industry stands at a defining moment. As organizations accelerate digital transformation, the challenge is no longer just adopting new technologies; it is ensuring those technologies support trustworthy decisions, sustained compliance, and reliable operations. This focus is central to the
The 2026 ISPE Europe Annual Conference in Copenhagen, Denmark, which took place in April, brought together students, recent graduates, practitioners, and industry experts from across the globe to explore the future of pharmaceutical science, engineering, and innovation. For Diala Raad, a pharmacy student at the University of Bordeaux and an active member of the ISPE France Affiliate, the...
For a clause that has been in force since 1997, 21 CFR Part 11 §11.10(e) is still remains one of the most under-implemented requirements in computerized GxP systems. Many quality and information technology (IT) teams reduce it to a single compliance checkbox: "we log who changed what, with a timestamp—done." But when an inspector looks beyond that surface-level interpretation, the gaps quickly...
Pharma 4.0™ has created a great deal of excitement across the industry, and rightly so. Digital tools are becoming increasingly powerful, accessible, and relevant to the daily realities of pharmaceutical manufacturing. Artificial intelligence, advanced...
For students and emerging professionals in the pharmaceutical industry, opportunities to engage with global leaders, explore cutting-edge innovations, and build meaningful connections can be transformative. The 2026 ISPE Europe Annual Conference is one such opportunity; bringing together experts, innovators, and the next generation of talent to exchange ideas and shape the future of the...
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...
