BIKASH CHATTERJEE
Pharmatech Associates, USA

Abstract

Pharma 4.0 offers efficiency at scale, based on data, security, and automation. Exploiting data from across the overall supply chain, Pharma 4.0 will use predictive analysis techniques that enhance business performance. Yet, by inserting the patient into the supply chain, advanced therapies complicate data acquisition and introduce global privacy requirements. The threat profile is higher from the perspective of data integrity and network security. This article examines key points to consider in a Pharma 4.0 supply chain, for organisations looking to bring advanced therapies to market.

Driven by digitalisation, Pharma 4.0 is envisioned as the next step in the evolution of pharmaceutical manufacturing. It reflects a shift to improving business performance through data analyses and structured decision-making across the entire pharmaceutical manufacturing value chain. At the centre of this new vision is the promise of ICH Q10, as it describes a comprehensive model for an effective pharmaceutical quality system implemented throughout the different stages of a product lifecycle, including good manufacturing practice (GMP) regulations.

By connecting the core elements across the business value chain, Pharma 4.0 is poised to create new levels of transparency and speed on the factory floor and in the supply chain, as shown in Figure 1.

Pharma 4.0 will also require higher levels of security, since connected systems heighten vulnerability, and solving these problems provides further new opportunities for the pharma industry.

The ambition of Pharma 4.0 to transform the development and manufacturing value stream from a reactive framework to a predictive framework is based upon analytics that address and anticipate poten ...