It is the GMP inspector whom the pharmaceutical manufacturer must convince of compliance with all GMP guidelines in his pharmaceutical plant and of the safety of its products. But what character traits do Russian GMP inspectors need?

Composition of the Russian GMP inspector team, first Russian GMP inspections worldwide

The history of the team of Russian GMP inspectors remains a short one, as it was only in 2015 that the Russian Institute for Pharmaceuticals and Good Manufacturing Practice (SID&GP) was first commissioned to carry out GMP inspections of foreign manufacturers. The first GMP inspection took place in Slovenia in April 2016. According to Vladislav Shestakov, the director of SID&GP, the first GMP inspectors were people with practical experience at pharmaceutical companies, and the team was put together based on recommendations from the employees of manufacturers. After further training, during which the newly qualified inspectors were able to gain European and global experience, they received a GMP inspectors license from the WHO.

During the five years following the first GMP inspection, the Russian regulatory authority developed its own methods for carrying out GMP inspections; however, it also complies with EU and WHO regulations. In addition, the SID&GP and the Russian Ministry of Industry and Trade (Minpromtorg) share their experience and methods with colleagues abroad.

Russian GMP inspectors are competent, fair and innovative

Not everyone is a born GMP inspector. Applicants are expected to have a university degree in the biological, chemical, medical or pharmaceutical field and must also have at least five years of experience in a leading position in quality assurance or quality control. The most important character traits of a GMP inspector also include honesty, tact and moral integrity. Knowledge of English is also required, although translators and interpreters for German, English and Russian are also used for Russian GMP inspections in the DACH region (also GSA region for Germany, Austria and Switzerland or German-speaking Europe).

Experience has shown that GMP inspectors from Russia are very strict, but at the same time competent and fair. Most of them are over 30 and have several years of experience as GMP inspectors. However, young employees also often demonstrate their high level of professionalism and expertise, surprising even their older colleagues.

What also characterizes the inspectors is their striking resilience. Vladislav Shestakov explained in an interview with the Russian newspaper Vedomosti that being a GMP inspector was a difficult job with enormous responsibility and high risks. He added that is why this work was very well remunerated. "You might return from Latin America and then leave for Japan. Physically, it's very demanding," says Shestakov.

At the beginning of the COVID-19 pandemic, when all borders were closed and no foreign inspections could take place on site, the Russian GMP inspector team proved to be particularly inventive and open to innovative solutions. The world's first online GMP inspection (so-called remote inspection), in which a Swiss site of the company Roche was inspected, was carried out by the Russian GMP inspectors. During this remote inspection, the Russian inspectors were assisted by pharmaceutical interpreters, among others.

During GMP inspections, Russian inspectors always adhere to the laws and regulations of their country. At first glance, it does not seem difficult to successfully pass a Russian GMP inspection, as the GMP guidelines in Russia are based on the corresponding EU guidelines and are basically just a Russian translation. However, this impression can be very misleading. Thorough preparation is essential for passing a Russian GMP inspection. The pharmaceutical company should also look for qualified Russian translators and interpreters early on. Their role in passing an inspection should not be underestimated.

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