MARTIN GADSBY
VP at Optimal Industrial Technologies, Bristol, United Kingdom

Abstract

Process Analytical Technology (PAT) has undergone rapid developments since its foundation, substantially redefining how it can be realised and the gains it can deliver to companies in the (bio)pharmaceutical sector. Thanks to key advances in digital technologies, it is now possible to enhance more than quality control and assurance (QC/QA) activities. Simultaneously, as companies take steps forward to succeed in the creation of Industry 4.0 applications, they are shaping new frameworks and driving new trends. Interoperability and convergence to realise the Industrial Internet of Things (IIoT) is one of the most prominent aspects that future-oriented PAT solutions are addressing. Similarly, advanced data analytics capabilities to improve process control and equipment condition monitoring in addition to more automated decision-making to drive responsiveness on the shop floor and in the laboratory as well as inter-facility standardisation are also in high demand and supported by the latest PAT applications.

INTRODUCTION – THE ORIGINS OF PAT
In a matter of two decades, PAT has changed considerably. It was first launched by the US Food and Drug Administration (FDA) between 2002 and 2003 as a key initiative to support more quality-centric operations within the life science and pharmaceutical manufacturing industries (1). The PAT initiative was launched to help reduce the production costs of medicines and other treatments by means of more efficient manufacturing and QC/QA methods.

To encourage companies to adopt PAT and ultimately offer more affordable access to medicaments, the FDA streamlined the mechanisms for implementing key PAT-enabling technologies, simplifying validation of quality-oriented production lines. The FDA and other regulatory bodies worldwide, such as the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), have been advocating for these solutions to raise the bar on data integrity and transparency. They updated their guidance on the necessary pharmaceutical data to ensure compliance, de facto favouring PAT-driven setups.

Given this, it is clear t ...