Fifty shades of product quality Improved quality through the symbiosis of compliance and digitalization
Change has become commonplace in the life sciences industry. It often occurs at a breakneck pace. There are two main drivers of this change. Firstly, tightening regulations and the resulting compliance requirements. Secondly, “Industry 4.0”, which brings automation, digitalization and a transformation of business models with it.
Production: greater safety at a lower cost
The purpose of GMP-driven production processes has always been to ensure product quality during production. Today, PAT (process analytical technology) can help analyze, control and optimize the production process completely automatically. This reduces production cycle times and expenses without compromising product quality. Indeed, it actually ensures a consistently high level of quality. At the same time, control laboratories need to carry out fewer analyses, as adherence to the critical quality attributes (CQA) and process parameters (CPP) can be monitored during the process, which (partially) automates approvals. Before digitalization, this would have been unimaginable.
Combined with serialization, this yields a distribution system that ensures product quality and whose automation minimizes examination efforts.
Pharmacovigilance: new data sources improve product safety
Complete monitoring of all used pharmaceutical products and medical devices is a common demand. Without digitalizing the real-world data collection process, however, this is virtually impossible to achieve. Digitalization is the only feasible way of obtaining more information about the effects of products on patients and users. Along with increasing product quality, this also improves the reputation of manufacturers. Strict and consistent pharmacovigilance can prevent between one third and half of all deaths from pharmaceutical drugs and a quarter of all side effects. The sooner the industry starts using more extensive data, the more effectively we can detect, minimize or even eliminate risks for our patients. The ideal time for this data utilization is during development.
Leveraging potential symbioses
Today, pharmaceutical companies have the means to collect a large volume of data during all stages of the value creation process and product life cycle; new analytical methods help us assess these data. This has allowed the industry to elevate its product safety and quality standards to a level that sets a benchmark across industries. The use of digital methods strengthens collaboration between patients, authorities and the industry. This acts as a driving force for further improvements to product quality. Blindly following every new trend related to digitalization and change is not necessary; instead, industry players must recognize opportunities for their own companies and make the most of them.
■ Sonja Fix
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- The buzzword “digitalization” obscures genuine opportunities – an interview with CEO Erwin Küng