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Daniel Flossbach
Daniel Flossbach
Home | Newsletter | UPDATE 1 | 2019 | Fifty shades of product quality
March 4, 2019

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.


Not only do the two drivers complement each other, they act like positive catalysts that mutually improve product quality in many ways. How can this symbiosis of compliance and digitalization be achieved in reality?

Everyone wants better product quality, even those of us who are suspicious of the digitalization hype. Quality improvements are a necessary requirement for greater value creation, and they strengthen the good reputation of a company. The life sciences industry has always been committed to delivering high quality. Together with the authorities, it substantiates this promise by way of guidelines and recommendations, such as the ICH and GxP guidelines. This compliance is a catalyst for the countless possibilities inherent to the digitalization.

At every stage of the value creation chain, there are opportunities for optimizing product quality. They may involve using more meaningful data in the development process, automated production monitoring systems, additional information about side effects, complete verification of the delivery chain and so on.

Improved product quality through the symbiosis of compliance and digitalization


Research & development: proving efficacy with better data

The most important transition has taken place in the development of new active substances and therapies, especially during the research phase. This process has become more precise and faster than ever, which also reduces expenses in most cases. Thanks to the introduction of digital biomarkers, research data contain a larger variety of precise information. Real-world pharmacovigilance data facilitates new methods of trend analysis, which improve our understanding of drug tolerability. The additional data then improves the quality of research findings, which leads to better products and better evidence of efficacy. Not only is this interesting for conducting studies, it is an important factor in the drug approval process.

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.


Distribution: greater transparency, lower effort

In the field of distribution, two developments are particularly noteworthy. Firstly, the possibility of securing and monitoring the distribution chain in accordance with delivery conditions based on GDP (good distribution practice). Secondly, serialization: an individual QR code is printed onto each unit of pharmaceutical packaging to prevent the circulation of counterfeit products. Again, this showcases the effectiveness of new technical possibilities in ensuring product quality and compliance. Data loggers and automatic data storage guarantee the security and transparency of the distribution chain and produce automatic notes and warnings in case of deviations.


Improved product quality through the symbiosis of compliance and digitalization


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