In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory landscapes, and emerging global challenges such as supply chain disruptions, and drug shortages have significantly impacted how we develop, manufacture, and deliver treatments. These factors underscore the critical need for robust validation approaches for computerized systems to safeguard patient...

The US pharmaceutical manufacturing sector is preparing for continued, significant growth over the next decade, fueled by robust investments and evolving market demands. At the same time, this growth presents significant challenges—chief among them, the imperative to attract and retain a highly skilled workforce and to integrate advanced technologies that streamline operations and boost...

In the pharmaceutical industry, expertise is essential—but connection is what turns expertise into impact. No single professional, company, or discipline holds all the answers to the challenges we face. Progress happens when experts come together, share knowledge, and build upon one another’s insights. That’s exactly what ISPE enables: a global network of professionals who not only advance...

The pharmaceutical industry is undergoing a significant transformation, moving away from traditional paper-based validation processes to adopt digital validation tools (DVTs). This transition began with electronic validation repositories, enabling the digital creation, uploading, and electronic approval of documentation—securely stored and meeting electronic records and signatures compliance...

The future of the pharmaceutical industry is being shaped by rapid advancements in digital technologies, automation, and data analytics. As we look ahead to 2025, the concept of Pharma 4.0™ is no longer just an aspirational vision—it is becoming a transformative reality that will redefine how medicines are developed, manufactured, and delivered to patients.

Lindsey Daniel, Director of Product Operations Strategy and Business Lead at Takeda, is an exemplary champion for and beneficiary of ISPE. Daniel embodies leadership and collaboration in numerous ways: as a mentor, mentee, friend, colleague, mother, and more. With over 12 years of active involvement with ISPE, she has served on various committees, including ISPE’s International Women in...

In the pharmaceutical industry, ensuring the safety, quality, and efficacy of products is paramount. With the increasing complexity of manufacturing processes, the growing reliance on computerized systems and advancements in technology, GAMP^® guidance provides a framework for validating and maintaining the integrity of computerized systems, ensuring they are fit for their intended...

The presentation by Ian Deveau, PhD, from the US Food and Drug Administration (US FDA) Office of Compounding Quality and Compliance at the 2024 ISPE Annual Meeting & Expo on 15 October 2024 provided an in-depth look at the US FDA’s perspective on drug compounding, its regulatory framework, and the significant events that have shaped current practices. Here is a summary of the key points...

Every dose of medicine represents a promise of quality—a commitment to safety, efficacy, and availability for the patients who depend on it. At the 2024 ISPE Annual Meeting & Expo, Jennifer Maguire, PhD, Director of the US Food and Drug Administration’s (US FDA) Office of Quality Surveillance (OQS), outlined how the agency is transforming its approach to pharmaceutical quality surveillance...

At the 2024 ISPE Annual Meeting & Expo, a session focused on lifecycle management considerations for cell and gene therapy was held. This session invited experts in their field to review...

Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety (AGES) provided a much-anticipated presentation on the requirements for data management in light of the revised Annex 1 at the 2024 ISPE Pharma 4.0™ and Annex 1 Conference in Rome, Italy in December 2024.

Imagine your favorite sports team. Maybe it’s a football club with a rich history, a devoted fan base, and an energy that electrifies the stadium. Some people are casual viewers—they check the scores, maybe attend a game now and then. Others are fanatics (sometimes even crazed fanatics). They wear the jersey, know the stats, engage in every play, cheer and yell at the team and opponents, and...

The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large molecules and cell and gene therapies, has been the fastest growing market in the pharmaceutical industry for years and this is not expected to change in the next few decades. In addition to products already on the market and new products in development, the market will additionally grow in...

As we approach International Women’s Day 2025, this year’s theme highlights the importance of accelerating action. ISPE’s Women in Pharma^® embodies these principles by creating a platform for connection, growth, and empowerment. Hear what these Women in Pharma® members have to say about the value of Women in Pharma on International Women’s Day.

The pharmaceutical industry is one of the most dynamic and regulated fields globally, where staying ahead of the curve is not just beneficial—it's essential. Professionals need reliable, up-to-date resources to navigate the complexities of regulatory requirements, technological advancements, and industry best practices. This is where the International Society for Pharmaceutical Engineering...

As aseptic processing evolves rapidly both from technological and regulatory perspectives, the 2025 ISPE Aseptic Conference will feature a full