The pharmaceutical manufacturing landscape is becoming increasingly complex, especially with new regulations and technological advancements. One of the most significant challenges facing the industry today is the implementation of Annex 1, which focuses on the manufacture of sterile medicinal products. The 2024 ISPE Pharma 4.0™ and Annex 1 Conference...

As the pharmaceutical industry navigates the complexities of digital transformation, the concept of Pharma 4.0™ emerges as a pivotal framework for integrating advanced technologies into business processes. The upcoming 2024 ISPE Pharma 4.0™ and Annex 1 Conference,...

At the 2024 ISPE Annual Meeting & Expo held in Orlando, Florida, USA, in October, a panel of global regulators and industry professionals addressed harmonization and regulatory convergence, digitalization, particularly the use of artificial intelligence (AI), and supply chain resilience.

At the 2024 ISPE Annual Meeting & Expo, held 13-16 October in Orlando, Florida, USA Nina Cauchon, PhD, Director, Regulatory Affairs -- CMC, Amgen, led a session on the global adoption status and implementation strategies for recent International Council on Harmonization (ICH) guidelines

Theresa Mullin, PhD, Associate Director for Strategic Initiatives at the US Food and Drug Administration’s (US FDA) Center for Drug Evaluation and Research (CDER), opened the 2024 ISPE Meeting & Expo in...

The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has always been one of the more future-focused technical conferences within ISPE. Originally called the ISPE Barrier...

In an era where technological advancements are reshaping every industry, the pharmaceutical sector is no exception. The 2024 ISPE Pharma 4.0™ and Annex 1 Conference is the gateway to understanding...

In an increasingly complex world, where the reliable delivery of power from point A to point B often depends on substantial construction and upgrade activities, the need for efficient project delivery has never been more critical. For manufacturers, completing pharma facility and process optimization projects quickly and cost-effectively can be challenging. As a result, many are exploring new...

The 2024 ISPE International Honor Awards were presented at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, in October. These awards provide the opportunity for the ISPE community to recognize and celebrate the dedicated professionals who volunteer countless hours to support ISPE and its mission.

This year’s 2024 ISPE Annual Meeting & Expo at Gaylord Palms in Orlando, Florida, USA was an inspiring experience, combining the energy of high-level industry discussions, networking opportunities, and moments of genuine connection. Despite the uncertainty brought on by Hurricane Milton, the conference went forward with an impressive spirit of resilience and adaptability. From insightful...

The future of manufacturing is not a battle between humans and machines. It is a collaboration that promises to redefine productivity and innovation. Industry 5.0 is poised to revolutionize how companies operate over the next decade, shifting the focus beyond mere automation and optimization to prioritizing the well-being of workers. This paradigm shift will transform workplaces, making them...

In September, ISPE released the second edition of their Good Practice Guide on Heating, Ventilation, and Air Conditioning (HVAC), which provides a detailed overview of HVAC considerations in the pharmaceutical industry. The second edition also reflects industry...

Daria Curtis works in quality assurance validation at AstraZeneca and is a member of ISPE. In this interview, conducted by Edyna Miguez, Membership Growth Manager at ISPE, Curtis shares her key areas of expertise, what prompted her to get involved with ISPE, how being a member has enhanced her professional career, and more.

In an era where advanced therapy medicinal products (ATMPs) are revolutionizing healthcare, the 2024 ISPE Pharma 4.0™ and Annex 1 Conference, taking place 10-11 December in Rome, Italy, and...

In this blog post, Rebecca Roscher – Project Manager at Bayer AG (Supply Center Grenzach) – shares how she rose from an ISPE student member to an Emerging Leader Representative, Ex-Officio, on the 2024-2025 ISPE International Board of Directors.

The 2025 Mentor ISPE program promises to be a transformative year filled with growth, collaboration, and valuable learning opportunities for both mentors and mentees. As ISPE mentors and mentees embark on this journey, they’ll have the chance to build meaningful professional relationships, gain fresh insights, and strengthen skills through guided support and shared experiences. Whether ISPE...

The 2024 ISPE International Honor Awards were presented at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, in October. These awards provide the opportunity for the ISPE community to recognize and celebrate the dedicated professionals who volunteer countless hours to support ISPE and its mission. This award was presented to the family of Antonio Moreira, PhD, to posthumously...