Today Pharma 4.0 is all the rage. Like other fads and buzzwords, it is being banded around like the new panacea for all ills etc. in our industry, but that is perhaps a gross misrepresentation. What it is is a recognition of a mechanism to develop the science and understanding of what effects, controls and enables quality, safety and effectiveness in the development and production of medical products. Over the last 10 to 15 years industry and the regulatory agencies have together progressed mechanisms and standards to redefine measurement, standards and key performance indicators in an integrated approach to assure quality attributes are maintained with sustainability. Coupled with a Quality Management System approach (QMS), Risk Management and the application of Process Excellence principles such as Six Sigma and Lean, we have now arrived at a point where quality has been enhanced and products can be reproducibly produced to a reliable specified standard. So, the next phase is using integrated databases with rapid data streaming capabilities access to many platforms, to push the concept further. This will employ Big Data Analysis, Predictive Analysis algorithms Modeling and the use of creative Artificial Intelligence algorithms (AI), to eradicate many of the deficiencies which have for decades plagued our industry.

Parts of this concept brings QbD into the forefront of modern process and facility operations as part of the equation to define the framework required to attain and maintain quality in the apparent New World Order of things. The shift to digitization as part of this process has helped to create the new infrastructure requirements and standards to enable the connection of data generation and use with specific equipment/instruments and personnel operating and managing. This interconnectedness through automation provides the prize of quality with the bonus of productivity and increased efficiency. Through the ability to collect information extending across many functional areas, not just manufacturing, the Internet of things (IoT), and Big Data Analysis facilitated through cloud-based data management platforms perhaps provides the defining differentiating feature of this New World Order termed, Pharma 4.0.

Although we’re not there yet, the coupling of these intelligent devices/instruments chatting and gathering information from disparate areas of the organization, makes the possibility of more informed decision making likely. With the advent of Artificial Intelligence into this mix the possibility of these decisions becoming autonomous of the operating personnel only further raises the stakes in terms of some hierarchical control of the entire supply chain. Presently for many companies, these systems are fragmented in terms of their integration, but given the regulatory and econo/political pressure to produce medicines to high quality and at the controlled acceptable price, those that don’t respond quickly and step up to the challenge will be left at a competitive disadvantage.