What is Pharma 4.0? Vol.1

Extract and further conversation on a keynote presentation given to the Interphex Japan by David Margetts on 27th June 2018, Tokyo
 
 
要旨：
アイオーティー(IoT)やインダストリー4.0という言葉を聞いたことがある人の多くは、こうしたテクノロジー主導の取り組みが、従来からの製造方法、設備機器、そしてプロセスにすでに急激な変化を起こしていることにも気付いているかもしれない。インダストリー4.0は医薬品産業にとってどのような関連性があり、我々はそれをどうやって実現していくのだろうか？ こうしたコンセプトに沿ったチャレンジの一つに、ロボット化、自動化、インターネット接続された埋込型センサー、統合型エンタープライズソフトェアなどが一つの複雑な未来型の複合体システムとなって我々のプロセスで動き、リアルタイムで自らが判断し、人が現在関与することで決まるロジックも変更してくれるような姿を”最終形“として思い描くようなことがある。こうした驚くべき構想を把握することは容易ではない。特に医薬品産業では、我々は重要な医薬品を製造するための製造プロセス管理やソフトウェアによる試験管理を通して厳格なGMP要件を常に満たさなければならないため、そのような急激な変化は受け入れがたい。本稿では、Pharma 4.0構想とは何かについて掘り下げて解説し、ある企業が未来の工場の実現に向かってすでに手掛けているいくつかのステップを紹介する。
 
Abstract:
Many people will have heard of the Internet of Things (IoT) and Industry 4.0 and perhaps are aware that these technology driven initiatives are already starting to disrupt traditional manufacturing methods, equipment’s and processes. But how relevant is Industry 4.0 for the pharmaceutical industry and how we will get there?
 
One challenge with these concepts is that we think of them in their ‘end state’, where a complex and futuristic combination of robotics, automation, embedded internet connected sensors and integrated enterprise software are running our manufacturing and making decisions in real time and replacing logic that is currently determined through human involvement. This amazing vision can be difficult to grasp and specifically in the pharmaceutical industry then such dramatic disruption can be uncomfortable as we must meet the stringent requirements of the GMP regulations through careful control on our operations, and careful testing and control over software that is used to produce critical medicines.
 
This article seeks to break down and introduce what the Pharma 4.0 initiative is about and explain the steps that companies are already taking today to advance along the journey towards the factory of the future.


So what is Pharma 4.0?
 
In reality today, then Industry 4.0 is still in its infancy across the world and there are no strict definitions of what it means and what the results will be for a specific industry. The term itself however is helpful to capture the overall development of manufacturing in the modern age to connect deeply the physical process and equipment with data and information systems. The goal is to gain the huge benefits associated with digitization such as improved control, visibility, understanding, prediction and feedback into manufacturing and ultimately enable software to make automatic responses so that higher levels of performance are reached above those possible with today’s manual and semi manual management of operations. Potentially, the last stages of this data journey will require advanced types of computation such as artificial intelligence (AI) that can evaluate the much larger data sets that will be available through integration and be able to learn and adapt our operations in real time to the changing conditions and longer term trends.
 
Pharma 4.0 is our industry’s interpretation of Industry 4.0, and it represents a shift from focusing on producing to a fixed specification to a systemized method of continuous evaluation and control so that our processes are self-adjusting based on running data and the information connected from systems all around the operation. This concept builds on the principles of Quality By Design (QbD) and Process Analytical Technology (PAT) that started over a decade ago in the industry, but until recently we simply did not have the information from electronic systems to make the data accessible for such advanced control. The Pharma 4.0 world will really become a reality when we have the base data platforms in place and they are integrated both to tools and devices that work alongside human operators for greater usability and awareness, and above to software able to enquire into data for self-learning and highlight, propose and take action on improvements and changes for the current running production. The benefits of Pharma 4.0 capabilities will be considerable, and not just limited to efficiency but through the great elimination of manual intervention and passing the human limits of assessing data then will enable higher levels of quality - this objective is of course particularly important in pharmaceutical manufacturing.