Pharma 4.0 represents the fourth industrial revolution in the pharmaceutical context. Robotics, artificial intelligence, nanotechnology, genetic engineering, 3D printing, are just a few examples of how technologies are now at the side of man in cultural and industrial growth. How to adapt the industrial revolution in the pharmaceutical sector? NCF discussed it with Teresa Minero, Founder and CEO LifeBee, President of ISPE Italia and Chair of the European ISPE Affiliates.

Teresa Minero, Founder and CEO LifeBee, President of ISPE Italia and Chair of the European ISPE Affiliates

Industry 4.0 in the pharmaceutical world

Pharma 4.0 is declined on several levels and on several dimensions. It appears justifiably as the key to achieving the major objectives that pharmaceutical production has always posed, summarized in providing safe, effective, timely pharmaceuticals and medical devices at sustainable costs and prices, and in harmonizing and standardizing processes on a global scale.

Opportunities and risks of pharma 4.0

Opportunities include the realization of an old dream of digitalization that deals with sustaining daily operations, from that of the operator and the employee to that of the manager. Not only that: a digitalization that supports analysis, synthesis and forecasts on moles of data, unimaginable until yesterday, all pursuing continuous improvement in a framework of sustainable compliance. An example over all possible: Batch Record.

The main risks of Industry 4.0 include cyber attacks and privacy risks. Not to mention even more complex issues: the potential social effects on the workforce and the need for new skills.

The reactions of local, small and medium businesses to Pharma 4.0

As we said earlier, a snapshot made today would photograph a multifaceted reality, at all levels and in a transversal way. With two small good important news. The first: many companies are developing plans for the development of their technology platforms and their processes in the direction of a paperless (we prefer to talk of less paper, or smart paperless) now identified as necessary to support and accompany their business development. The good news is that these companies often do not talk about Industry 4.0 at all, even if the contents largely coincide. The second. Three quarters of the Italian pharmaceutical world (for sure a large part of those exporting) are rushing to realize what is necessary for the great theme of serialization. A full 4.0 made of vertical integration, from machines to regulatory bodies, and horizontal integration from the company pharmaceutical to the pharmacy or patient. All because of the mandatory requirements of many important countries, including a European directive that sets the deadline for February 2019. Many still have not been able to evaluate some important side benefits of serialization. For example, the extraordinary possibility of a positive review of its supply chain, also and very much in collaboration with its present and future partners.

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