Everybody in the process industry is currently addressing the industry 4.0 topic. The question is whether all ideas and principles of this new industry paradigm be applicable in the pharmaceutical industry too.
Pharma is highly regulated and has a lot of functioning but antiquated designed products, requiring conventional processes for their manufacturing. What added value will automation bring to the current situation? What opportunities will the end-to-end integrated system of all computerised systems, vertically and horizontally, add to agility, flexibility, productivity and cost of our pharmaceutical operations?
ISPE in Europe has founded a new Special Interest Group (SIG): “From Industry 4.0 to Pharma 4.0“. The Pharma 4.0 SIG initiated discussions around the concerns that the automation factors are causing in production. It is a complex pharma challenge and the goal is to specify Pharma 4.0 and to differentiate it from the common “Industry 4.0“ concept, with the focus on maturity level models integrated into the programme.