How Does the Pharma Industry Embrace and Apply Industry 4.0?

The fourth Industrial Revolution, also known as Industry 4.0, is characterized by increasing digitalization and networking of value chains, business models and products. To ensure future success in the delivery of therapeutic medicines to patients, the International Society for Pharmaceutical Engineering (ISPE) and its members developed a roadmap to introduce Industry 4.0 to the pharmaceutical industry as Pharma 4.0™. The goal: Enable pharma companies and its suppliers to use the full potential of digital solutions and provide faster innovations. 

The use of new technologies offers pharmaceutical companies a wide range of opportunities for process optimization. The entire life cycle of drugs and pharmaceutical products can be covered: from researching new ingredients and therapies, through manufacturing and packaging, to distribution and application.

Digitization is an important part of Pharma 4.0™ by connecting everything and creating new levels of transparency. In order to understand which Industry 4.0 automation and digitization technologies can be used and what implications arise from the increasingly complex regulatory challenges in the pharmaceutical industry, business cases need to be developed.

To better understand what is behind Pharma 4.0, ISPE presents some theses. These include:

  •  In difference to common Industry 4.0 approaches, Pharma 4.0™ embeds health regulations best practices
  • Pharma 4.0™ breaks silos in organizations by building bridges between industry, regulators and healthcare and all other stakeholders
  • The Pharma 4.0™ Operating Model incorporates next to IT also the organizational, cultural, processes & resource aspects
  • Pharma 4.0™ is not a must, but a competitive advantage. Missing Pharma 4.0™ might be a business risk
  • When moving from blockbusters to nice products and personalized medicines, Pharma 4.0™ offers new ways to look at business cases

How does the digitization of pharmaceutical companies actually work?

IoT platforms play an important role in the contextualization and analysis of data. An IoT platform is a cloud-based solution for use within the Internet of Things (IoT). It enables the simple, secure and scalable networking of physical objects such as IoT devices and computer-based systems. In any case, the use of new technologies also includes Augmented Reality (AR). By linking IoT and AR, cost and resource savings can be made. In addition, AR can also support employee training and daily operations, for example, the maintenance of equipment.

To further advance the development of the roadmap, ISPE has established several working groups to address different thematic areas. A comprehensive overview of the digital approach to implementing Pharma 4.0, as well as information on the individual working groups involved, can be found on the ISPE website.