Pharmaceutical companies at the global level will increase investment in innovation and support for a high level of quality of medicines, international expert in GMP Wolfgang Schumacher has said. “In the early 1990s there was rather a broad understanding of what quality is. Over the years, this understanding has become more formulated and detailed, supported by more stringent rules and regulatory government policies,” he told Interfax-Ukraine as part of a master class “Integrity of Data for Laboratories and Production” for employees of Farmak Pharmaceutical Company (Kyiv) involved in the pharmaceutical quality system.
According to the expert, now, due to the presence of an increasing number of regulatory requirements, the concept of “quality of medicines” is also becoming increasingly regulated. “Back in the 1990s, we could produce a quality product without having a large number of regulatory requirements, but in recent years the requirements have become more detailed. New regulatory documents are issued. New regulatory documents are about ten times larger than the previous ones,” he said.
At the same time, Schumacher stressed that increasing the number of regulatory requirements obliges pharmaceutical companies that comply with GMP standards to strengthen the training of new personnel in GMP, including those related to legislative requirements that are not specified in the documents. According to him, European pharmaceutical companies pay more attention to quality than, in particular, American companies, despite the fact that the U.S. market has more regulatory requirements.
“European pharmaceutical companies are most focused on quality products. The American market is more documented, with lower quality in its products. In the U.S. market the documentation and the process of documenting are better than in Europe, but in practice there is not everything as good as in Europe,” he said.
At the same time, the expert noted Farmak’s responsible approach to the issues of quality and innovation. “It is very noticeable that the Farmak team is dedicated to its work and very motivated, which is very good. The life of each company lies in its team,” the expert said. The expert also noted that small and medium-sized pharmaceutical companies are “more pragmatic in their approach to quality, while large companies very often follow the rules.”
According to the expert, priority investments in quality are “investments that help develop people, and “it is necessary to invest in the motivation of the team.” “I think that Ukraine will face the same problems that other countries faced as well. Attracting personnel will be more expensive than buying equipment,” he said. At the same time, the expert noted the high expenses for innovation that pharmaceutical companies have to bear.
