The (GMP) rules suffocate medicial innovation, but there is another way


GMP, or Good Manufacturing Practices. In a medical production environment, it’s a kind of forced holy grail that must be complied with, or your company and product will face the music of the inspectors for any violations. GMP’s are the rules within which development must take place, and there is little that can escape the GMP’s rules. Software, equipment, instruments, even the number of particles in the air are all under scrutiny. Everything must be GMP-proof and kept up to date, otherwise, there is a good chance that your expensive and newly developed medicine, therapy, or treatment will not pass the inspection. GMP, therefore, has a completely different meaning for many laboratory technicians: Give me More Paper. For many companies, the rules are stifling and suffocating medical innovation. However, that does not mean that there are no alternative options!

Too big a puzzle

Let’s face it, rules in the medical industry are a necessary evil. Nobody wants to market a drug or medical innovation that is not developed and produced according to strict standards. The risk of unpredictable side effects, however small, is not worth the risk. At the same time, there is such a barricade of rules that most labs are happy to be able to do their job for a long time without any innovation. No matter how great the possibilities of digital techniques and new agile working methods are if everything must be GMP-proof, it is too big a puzzle for many pharmaceutical companies to even start on.

In need of renewal

On the other hand, the medical industry is in urgent need of renewal. Over the years, the complexity of research has increased, the number of rules has increased and the costs per newly developed drug have increased enormously. As you can also see in the chart below.

Chart developed drugs
Source: Lost in Translation – Bridging the preclinical and clinical worlds concepts, Examples, Successes and Failures in Translational Medicine by Attilla Seyhan

The hard numbers

Due to the enormous regulatory burden, in combination with an outdated working method, it now easily takes 12 years before a medicine sees the light of day. 49 percent of all newly conceived products do not even reach their first threshold of validation because they are not effective or feasible enough to pass through all the red tape and regulatory hoops.

The GMP elephant

Digitization, AI, miniaturization, and IoT are all techniques and technologies that can make a significant contribution to a more efficient lab, resulting in a substantial reduction in R&D costs. At the same time, there is an obvious “GMP elephant” in the room. You can completely transform your lab into an IT mecca, but if that leads to a stream of products that do not make it to the finish line due to bureaucracy, then it won’t make the pursuit of innovation worth it.

Innovation must therefore go hand in hand with both regulation and the GMP-proofing of these new techniques.

GMP approval is doable.

In collaboration with LINKIT, various organizations have shown that it is possible to innovate within the highly regulated environment of drug development. They have shown that it is indeed possible to get new lab environments and work and production methods GMP-proof. If you follow a clearly insightful process in which the user requirements are clearly described and your validation and qualification process is in order, then a lot is possible in consultation with the inspectorate.

Culture change?

The GMP elephant may seem big and insurmountable, but it may be more of a mouse with a big shadow in some cases. Success is possible, provided there is good cooperation between IT specialists and scientists. A good starting point is to carry out an inventory that gives you an overview of the IT options as well as the paths to innovations. That way, you can make informed decisions on whether to carry out an important IT process.

On the other hand, this technology in many ways is still in its infancy and thus the introduction of IT solutions is often a matter of taking a chance or being the first to put their toe in the “cold” water. Who dares?