Article written jointly by Beatrijs van Ledekerke (PricewaterhouseCoopers) and Ingrid Maes (Siemens) reproduced with kind permission of ISPE
Process analytical technology (PAT) has the potential to deliver significant shifts in the economics of the pharmaceutical sector. In the two years since the FDA published its guidance on PAT in 2004, there has been a wealth of research and comment articles on its adoption by the industry. This article discusses whether the literature matches the reality of the challenges faced inside companies, whether company practice and studies take too narrow a view of PAT, and what issues should be considered if the full potential of PAT is to be achieved.
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