It has been a long journey from the development of primarily manual aseptic processes to fully automated systems that do not require manual intervention. Looking back in history, it was a step-by-step development forward to the current contamination control strategy (CCS) many decades ago. The risk of contamination of a sterile product from the environment (room) and the people who do work in...

As a woman of science, I can confidently say that I believe in magic. I believe in the magic that spurs from innovation rooted in desperation, necessity, and determination.

When I started working in the pharmaceutical industry, I was looking for ways to grow my knowledge, my community, and my skillset. When I founded the Emerging Leaders committee within the ISPE D/A/CH (Germany, Austria, and Switzerland) Affiliate, I knew I had found that way.

As we head into 2023, it is hard to believe that it has been four years since the COVID-19 pandemic started to impact our lives and transition us to a new normal. It is also amazing how much technology and innovation continued to advance in those four years to allow our industry to develop new vaccines and innovative products to meet the world’s challenges.

Building off of the success of the 2022 ISPE Aseptic Conference, the program committee has developed a robust program covering key areas in aseptic manufacturing, processing, and filling for students, emerging...

Cultural Excellence is the expressed and implied ways in which an organization operates. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. Culture determines quality outcomes by affecting the organization’s ability to identify and act upon near-miss shortages, ensuring the integrity of its data,...

ISPE’s Women in Pharma^® group strives to tackle unconscious biases that limit women, and other marginalized groups, within the pharmaceutical community. Over the last few years, the group has grown to be a global force across borders, connecting industry professionals through regional and international programming, including having a presence at the 2022 ISPE Annual Meeting &...

Multi-Use Filling Line for RTU Syringes, Vials, Cartridges and Bulk Vials - Photo courtesy of INCOG BioPharma Services

“Leading Edge, Not Bleeding Edge”

The definition of technology is “the set of knowledge, skills, experience, and techniques through which humans change, transform and use our environment in order to create tools, machines, products...

ISPE’s Women in Pharma^® ended the year strong with their latest webinar: Digitalization in Business Processes that Support Sustainability & Economy of Means.

Change from default private to default public within the company?

We are The Culture Club, a self-formed cross-COP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the...

Excellence is everywhere, and it must be illuminated. For the fourth consecutive year, the annual ISPE Italy Affiliate Award for women in the pharmaceutical sector will be organized by the local group of ISPE Women in Pharma® (WIP). This important initiative was created to celebrate the commitment, perseverance, professionalism and competence of the women who work in this sector, qualities...

The ISPE Singapore Affiliate 2022 Conference and Exhibition is a WRAP! I was fortunate to chair both the pre-conference symposium opening plenary and the ‘Post Pandemic Transformation’ track.

A key challenge in life sciences is the detrimental effect of unplanned downtime and lost batches due to unanticipated equipment failure. Traditional maintenance programs are calendar or condition-based and can range from being overly conservative to reactive, leaving money on the table (over-maintenance - “just in case”), or jeopardizing productivity altogether. As described in the ISPE Good...

As one of the founders of Cheme Engineering, Nik Krpan was instrumental in the start-up of the company. He became president of the company in 2012. Nik says that leading the company through continued growth has been an exciting aspect of his career. “We started with five people and now we have more than sixty. It’s been really rewarding to be part of a creating an environment where people can...

The 2023 ISPE Aseptic Conference will devote one entire day to case studies related to aseptic manufacturing projects. For us, seeing the real-life challenges that the industry is facing and how project teams...

ISPE is pleased to announce the complete Advancing Pharmaceutical Quality Program (APQ) Program is now available with the release of the fifth and final guide.

By the ISPE Regulatory Team

ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. Support for that mission was on display at the 2022 ISPE Annual Meeting and...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin, Ireland on 4 October 2022. Since the first meeting of the PIC Committee in 1972, PIC/S has come a long way! The symposium was titled “Thriving at 50 and Striving Forward” and was aimed at promoting and...

As we are all aware, the COVID-19 pandemic has had a unique, world-wide effect on the pharmaceutical industry as well as health authorities. At the height of the pandemic, and continuing as it appears to wane, health authorities have not been able not carry out normal, in-person inspections of pharmaceutical manufacturing sites. However, in the ”Age of Covid,” using the Internet and associated...

The 2022 ISPE Singapore Affiliate Conference & Exhibition featured a regulatory roundtable discussion on the Future of Pharmaceutical Inspections.

On 17 August 2022, four international regulators discussed how the Covid-19 pandemic had taught regulators to look for alternative ways of doing GMP inspections and also to rely more on each other to make determinations on the GMP status of manufacturers of medicines.

A look through the lens of GAMP 5® Second Edition

IT Infrastructure is a broad term that encompasses both the platforms upon which business applications run, as well as the services that keep these platforms and applications running. Figure 1 below shows this landscape.

This article shows how non-supervised artificial intelligence (AI) methods can strongly support common processes in the pharmaceutical industry such as wet granulation drying. The techniques used demonstrate how continuous process optimization can be enabled and the process control strategy is permanently updated while keeping product quality under strong assurance and also increasing energy...