When you say pharmacy, you say compliancy. Bringing new pharmaceutical products onto the market is subject to very strict rules regarding the development, manufacturing and control of these products. Medication must meet quality requirements and comply with regulations, like Good Manufacturing Practice (GMP) guidelines, in order to prove that a product is correctly prepared, packaged, labelled and traceable. To guarantee full compliance of their products, pharmaceutical companies invest a lot of money to comply with all the required rules. One might expect that this attention to and investment in compliancy of products automatically leads to high quality built into the production process, but this is not always the case in an industry that has to worry about audits from many authorities.
And these authorities are inclined to focus mainly on compliancy rather than quality. An example to illustrate the difference between compliancy and quality: a single dose of medicine is produced from tissue derived from the patient. Since the delivery system is a vaccine, a sample needs to be produced to test the vaccine microbiologically. However, the vaccine’s active ingredients are only active for a couple of hours. The drug needs to be administered immediately after production but there’s often not enough time to test the vaccination on microbiological contamination. In the meantime, due to advanced process design and control, the manufacturer can prove that he has the process completely under control and that products aren’t contaminated. In the end, the product is only tested microbiologically to comply with the rules, not to guarantee the quality of the products.
Another premise to keep in mind regarding quality is that the focus on bringing medicines onto the market as soon as possible actually creates an inefficient quality system. It takes eight to twelve years to bring a new product onto the market. Considering that most patents expire after twenty years, companies don’t have a lot of time to earn back their R&D costs. Some products don’t even make it onto the market, and these costs are not earned back at all. Companies are forced to speed up their time-to-market and they are focused on the validation of products. The result is less focus on developing optimal production processes controlled by efficient and effective quality systems.
One important thing these companies forget, is that good quality management can actually save money. Most pharmaceutical companies produce sub optimally, when assessed by six sigma – a set of statistical techniques and tools to improve processes, applied in various industrial sectors. Where the automotive sector aims to produce on 6 sigma, pharmaceutical companies score an average of 2 sigma.(1) This does not imply that pharmaceutical companies bring bad products onto the market. It’s just that their own manufacturing processes and complex quality systems often lead to inefficiencies and incompliances.
The solution: companies need to focus on controlling the risks in their manufacturing process, embed quality as well as compliancy in their product and manufacturing process itself and control the process by a quality management system based on scientific proof. That way, you can proof auditors that you adequately manage risks associated with quality, and you can guarantee that you are compliant with relevant regulations while increasing the profitability of your business. QbD helps companies in the pharmaceutical industry to increase quality in and cost efficiency of their production process. How? By implementing the quality by design concept and through provision of insights in the entire manufacturing process, instead of only testing the finished product. Together, we aim at compliancy, quality and cost efficiency!
(1) ‘Flawless: fom Measuring Failure to Building Quality Robustness in Pharma’, McKinsey & Company (2014)