The 4th All-Russia GMP Conference, which was held from 23 to 25 September 2019 in the Kaliningrad Region, is highly significant for both the Russian and the international pharmaceutical industry. It provides opportunities for regulators as well as GMP and pharmaceutical inspectors to discuss in detail the current standards of “Good Manufacturing Practice“ (GMP) and its future. Last year, over 20 regulators from 15 countries participated in the conference. Since we from the Nuremberg specialist translation and simultaneous interpreting agency AP Fachübersetzungen have already often interpreted at Russian GMP inspections and translated many pharmaceutical texts, this insightful large event aroused our particular interest.
The theme of this conference was: “Good Manufacturing Practices: Uniting Industry and the World.” And rightly so, because Russia exported pharmaceutical products to over 120 countries in 2019, above all to CIS countries and countries of the Eurasian Economic Union (EAEU). The EAEU is working hard to introduce uniform regulations at GMP inspections for all its member states and to establish a common market for pharmaceuticals as well as contacts with international regulators. This tendency towards GMP standards that are accepted worldwide can be seen in many European, American and Asian countries since guaranteeing high quality of medicinal products beyond national borders should be a pharmaceutical producer’s top priority. Our highly qualified and experienced Nuremberg specialist translators also commit themselves to the keyword quality: they guarantee that the language, content and style of your pharmaceutical, medical, technical and legal specialist translations are correct by having a professional proofreader check the finished translated text according to a dual control system. All the specialist translators and proofreaders at AP Fachübersetzungen are top-qualified linguists and only translate into their native language(s).
Every year, the GMP Conference offers its participants various information events. In 2019, the topics of these events included “Good Laboratory Practice” (GLP), “Good Distribution Practice” (GDP) and “Good Veterinary Practice” (GVP). A workshop on the topic of GMP inspections was very well received by the conference visitors. It was organized by Elena Denisova (the Deputy Director of the Pharmaceutical and Medical Industry Development Department of the Russian Ministry of Industry and Trade) and by Natalia Chadova (the Head of the Medicine Manufacture Inspection and Expertise Department of the Federal State Institution “State Institute of Drugs and Good Practices”).
We from AP Fachübersetzungen in Nuremberg would have been happy to be invited to this very exciting workshop as simultaneous interpreters for the languages Russian and English because it gave representatives of pharmaceutical companies the opportunity to talk about their practical experience at GMP inspections. For example, Olga Maklakova, the Quality Director of the company “Akrikhin”, also mentioned the difficulties that GMP inspections can cause for pharmaceutical producers, especially concerning CAPA (Corrective And Preventive Actions). Furthermore, Heinz Schmidt, the Director of the “Merck“ Life Science Department in Russia and the CIS, explained what developments are currently taking place at pharmaceutical companies worldwide. Medicines are being personalized, the requirements for carrying out processes and the production cycles are being changed, and capital expenditure is being minimized. Therefore, he said, it is necessary for GMP inspectors to have in-depth knowledge of complex processes in the area of technology. In addition, Schmidt emphasized the importance of cooperation between pharmaceutical producers and raw material suppliers to guarantee impeccable quality of pharmaceutical products. Finally, Natalia Chadova brought up the fact that pharmaceutical companies and inspectors can often come into conflict if deviations from the applicable GMP standards of the respective country are found during a GMP inspection at a pharmaceutical company. She said that it was also extremely difficult to categorize the deviations according to certain groups as well as product and production types since this placed high demands on the inspectors.
During the workshop, the participants even had the opportunity to directly ask the representatives of the regulatory authorities questions. Most frequently, the visitors wanted to know how the GMP inspectors assess the implementation of the labelling stage and how an explanatory note has to be submitted ideally to the relevant authority if the inspection does not take place on-site. Moreover, the participants were very interested to find out how the maximum number of deviations for a positive assessment at a GMP inspection is determined.
However, we remain confident that our simultaneous interpreters for Russian and English will be available for the next workshop of this kind at the GMP Conference 2020 and will be able to prove their professional expertise when interpreting in the pharmaceutical area.
The Russian “Federal State Institute of Drugs and Good Practices“ has set itself the goal of getting not only pharmaceutical producers based in Moscow, but also pharmaceutical companies from other regions of Russia involved in GMP-related topics and organizing information events regarding international GMP standards for them. These events show how the health system and the pharmaceutical supply are developing at pharmaceutical production sites in different parts of Russia.
The city of Yaroslavl in central Russia was chosen as the event venue for the very first All-Russian GMP Conference in 2016. In 2019, the 4th All-Russian GMP Conference took place in the Kaliningrad Region in western Russia, and the Governor of Kaliningrad, Anton Alikhanov, emphasized the advantages of this city for investors. Thus, for example, income and property tax for pharmaceutical companies based within a Special Economic Zone are significantly reduced for a period of 15 years. Besides, Alikhanov said, pharmaceutical manufacturers can import components from foreign countries and then again export their products to other countries, with the Kaliningrad Region paying the export custom duties. For the reasons mentioned, Kaliningrad already has over 73 foreign investors and even developed a staff relocation programme by opening a new engineering centre in 2019.
With several in-house translators and interpreters, we from AP Fachübersetzungen specialize, in particular, in the language Russian and the specialist area of pharmacy. The highly qualified simultaneous interpreters of our in-house Russian department have already interpreted professionally at numerous GMP inspections by Russian and Belarussian authorities and were also commissioned to interpret at GLP and GCP inspections as well as audits. For this kind of inspections, the choice of the interpreters has to be carefully considered since their work involves a very high degree of responsibility, and the quality of interpreting has to be excellent. This can only be guaranteed if the simultaneous interpreters have been specially trained to become interpreters in the area of pharmacy and have several years of professional experience. Only in this case do they have extensive knowledge of the pharmaceutical, technical, medical, chemical, biological, microbiological and authority-specific terminology and are thus able to transfer the content spoken during a GMP inspection correctly and precisely into another language within a very short time. For years, we from AP Fachübersetzungen have impressively proved that we also fulfil all these criteria at other occasions, not only at GMP inspections, but also at trade fairs, meetings, congresses, conferences and court hearings!