Pharmaceutical production errors – why fines are not the answer24/02/2016 - Martijn Reniers, Managing Partner at Quality by Design
45,000 euros. It’s the fine pharmaceutical companies have to pay when they are unexpectedly unable to deliver certain medicines. The Dutch minister of Public Health, Edith Schippers, is investigating the arguments for raising this fee. One of the reasons is the commotion about a shortage on thyroid gland medicines early this year, due to a relocation of production. Dutch Member of Parliament Hanke Bruins Slot points out that the current fine isn’t of big concern to multimillion dollar industries within the pharmaceutical sector.
Is it wise to punish pharmaceutical companies this way? In my opinion it’s not. Think about it. When a pharmaceutical company is suddenly no longer able to produce a certain medicine, it loses a lot of money. The economical damage is then big enough without a fine. Fines don’t prevent companies from making the same mistake in the future, because there isn’t a single company in the world that interrupts its production on purpose. We need to find another solution. And to do so, we need to investigate the cause of a potential production errors.
In the case of the thyroid gland medicine, it was technical malfunctioning due to relocation. Relocation is not uncommon within the pharmaceutical industry. Companies want to increase their capacity, guarantee business continuity by spreading production and create more specialized plants. Besides, the production of medicines has never been a key task of pharmaceutical companies. These companies are mainly concerned with the invention of new products and the delivery to customers. That’s why they increasingly outsource production to contract manufacturers.
All these developments bring along one important risk – data, equipment and responsibilities need to be transferred from one party to another. This so-called ‘technology transfer’ lays the foundation for further production process, control strategy and validation of a product. However, every company makes use of other policies, approaches and processes. They need to develop a standardised framework to serve as lingua franca and ensure thorough understanding between sending and receiving unit. By creating a technology transfer framework in an early phase, companies guarantee successful validation of products later and prevent problems like technical issues due to relocation.
Some tips to set up a successful framework:
A promising start
Don’t underestimate the value of thorough preparation. Always start your technology transfer with clear agrees on legal aspects – like license rights and the use of technologies – and practical aspects – like way of reporting between sending and receiving unit.
It’s all about data
In phase two, both parties exchange information regarding specifications, tests, materials or production processes. Keep in mind two things. Make sure you transfer the right information, for example by using a general checklist. And secondly, think about the best format, so all parties are able to recover relevant information in later stages.
Be prepared for anything
Don’t bury your head in the sand – tackle future problems now. Some issues ask for priority over others. Like the acquisition of new equipment. Make sure you identify requirements as soon as possible – buying new equipment usually takes about a year.
Take advantage of your own people
You may have more expertise in stock than you might think. Like employees who where previously involved in a previous technology transfer. Benefit from their knowledge and lessons learned, and involve them in the process from the very first start. Don’t hesitate to ask for a fresh look either, especially from an extern specialist. He will be able to tell you where to start and how to anticipate upcoming problems.
The right knowledge and help enable companies to accomplish successful technology transfers. The only solution to prevent companies from errors in their production process, is to help and support companies instead of punishing them with fines. This way we lay the foundation for solid technology transfers between companies in the entire pharmaceutical industry. So they can focus on their duty– consistently providing patients with important medicines.