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The Challenges in Starting 4.0 Projects





Pharma 4.0 is now a prevailing reality that has many advantages such as in-line and in-time control over manufacturing operations and faster decision-making (1-2). Nevertheless, the dangers of investing in wrong ways exist; investing in technologies that suit the company needs is strongly advised, that is, the ones that help provide the most efficient solutions to the problems faced by the company. Peter Guilfoyle writes that “the potential for Pharma 4.0 is so huge, and so wide, that a lot of pharmaceutical companies rushing to adopt the technology haven’t first paused to figure out the root goals that they are trying to achieve, and what main problems they are trying to solve”.

Launching a digitisation project indeed requires an approach to be chosen according to the expected benefits. However, all biopharma companies have at least two objectives in common: reducing operational supply chain costs and scaling down the data recording administrative burden. Investing in Pharma 4.0 technologies should aim to achieve these goals.
 

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About the author


Denis Decubber has a degree in Chemical Engineering. His professional experience covers quality management systems and especially GMP/GCP/GTP systems, more specifically those dedicated to cell and gene therapy operations. This certainly provides added value when it comes to understanding customers’ business processes: manufacturing and quality control processes, clinical study processes, support processes related to premises, equipment and subcontractors, and improvement processes (for example, risks, deviations, and out-of-specification issues). He is Chairman of SalamanderU’s board of directors.


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