As part of the celebration, ISPE invited its community to participate in the Submit Your ISPE Story campaign. The initiative encouraged members to share personal experiences that highlight the value of ISPE, with select submissions recognized for their insight and impact.
Among these was an award-winning story from Dariusz Kuzawinski with DARECK, of the ISPE Poland Affiliate and GAMP® Community of Practice. His reflection highlights the lasting influence of ISPE’s GAMP® guidance and its role in shaping more effective, practical approaches to validation. In the testimonial below, Dariusz shares how his long-standing engagement with ISPE has supported both his professional growth and his contributions to improving industry practices.
Dariusz Kuzawinski on Turning Validation into Value
My journey with ISPE began back in 1997, with a meeting with David Selby at the international Pharmaceutical User Club, where GAMP® (GAMP 2 was in effect at the time, if memory serves me correctly) was held. He talked to us about what GAMP is and how it can be useful in the pharmaceutical industry. I was working for GlaxoSmithKline at the time. Since then, I've found ISPE's publications, not just the GAMP Guides, very useful on numerous occasions.
Later, in 2008, I joined the ISPE GAMP Community of Practice. I greatly appreciate the benefits of introducing GAMP 5.
In September 2023, I had the great joy and pleasure of presenting the changes to the ISPE GAMP 5® Guide (Second Edition) at the ISPE Poland Affiliate forum. For me, the second edition is a breakthrough. It's the culmination of what I've been advocating and convincing my clients about during validation activities. I felt grateful to the editors of the second edition when I saw this connection between my experiences and the second edition's records.
And how did the ISPE GAMP 5 Guide (Second Edition) help me? Firstly, critical thinking. Because I often saw validation documentation that was of no use to anyone. The only drawback was the high cost of conducting the validation itself, and then the validation significantly hindered the continued maintenance of the system in a validated state.
Another aspect that was extremely important to me was that IT tools and infrastructure (often perfectly managed by IT departments)—thanks to the ISPE GAMP 5 Guide (Second Edition)—suddenly didn't need to be validated. And you could rely on ISPE GAMP 5 Guide (Second Edition). Previously, explaining to various people that this was pointless, because besides creating additional documents, we weren't contributing anything significant to the process or system—was often doomed to failure.
The third, and extremely important aspect from my perspective, was that at the level of documentation and procedures related to managing a given system, the amount of work associated with change control and implementing numerous corrections to the systems could be effectively reduced without complex validation activities. I'm referring here not only to "review by exception," but also to the level of assessing the criticality of certain functionalities and excluding some functionalities as entire sets from the need for validation.
It was thanks to GAMP 5 that I understood that, just as validation of computerized systems (understood as hardware, software, infrastructure, combined with the processes they support and the people who run them)—actually translates perfectly to all other validation processes, not just computerized systems. Because with this approach, by looking more at the process—you can actually improve processes.
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