AI, DI, OverRegulation: Impact on QMS

Karen Taylor, Pci Pharmaceutical Consulting, BPharm MSc, Jerusalem, Israel (karen@pcipharma.com)

Artificial Intelligence has been around quite a while as has Machine Learning (AI/ML). Only fairly recently, have we woken up to its dangers and as is usually the case, far too late industry and regulators are begging for regulation. No one questions the need for regulation, the question is how much and…how? Data Integrity (strangely, one subset of the AI riddle) has overtaken the Pharma industry to a level where it is questionable if any company could pass a rigorous, focused, multi-person inspection on the topic. Over regulation stymies innovation. Our QMS is dysfunctional as we slap yet another plaster over the last inspector’s personal opinion (sometimes covering sometimes removing the one before). We need holistic systems. The OOS / deviations CONTINUE to recur despite metrics, KPIS etc. The solution of yet another SOP has failed. Pharma is scared to innovate. The cost is too high. Breakthrough change is required agreed on by industry and regulator regarding implementation of innovation, QMS, inspection. More of the same is simply making the drug shortage worse.