Since 2016, the Russian State Institute of Drugs and Good Practices (SID&GP) has been responsible for the global implementation of Russian GMP inspections, among other things. Even at the beginning of the first GMP inspection, the institute could look back on decades of history.

History of the institute since 1973 and significance for the Russian pharmaceutical industry

The Russian State Institute of Drugs and Good Practices (SID&GP), based in Moscow, was established in 2014 by order of the Russian Ministry of Industry and Trade (Minpromtorg) from the State Institute for Blood Substitutes and Medicinal Preparations. Since its foundation in 1973, the initially Soviet scientific research institute has been involved in the development of hormone preparations, blood substitutes and blood preservatives. In addition, the Moscow-based institute also developed and implemented several new methods of quality and production control, so that it already had its own procedures for this before it was authorized by the Minpromtorg to carry out GMP inspections abroad in 2016.

One of the even older predecessors of the institute, the All-Soviet Scientific Institute for Technologies of Blood Substitutes and Hormonal Preparations, founded in 1973, was one of the leading institutions of the pharmaceutical industry in the USSR. It developed medicinal products that previously had to be imported from abroad, supplying not only the Soviet Union but also other countries in the Eastern Bloc. The research activities continued even after the transformation into the Institute for Blood Substitutes and Medicinal Preparations. One of the most important developments on which the Russian institute conducted research from the 1980s until the 2010s was the medicinal product mucosate based on chondroitin sulphate. Today, the drug is produced in the form of solid medicinal products and as an ointment.

How SID&GP experienced the stormy times of the 90s

In the 1990s, Russia underwent a complete transformation of its economy, society and political system. Science was severely underfunded during this difficult period, and many institutions had to close or lay off their staff in order to cut spending. Fortunately, the State Institute for Blood Substitutes and Medicinal Preparations managed to continue to exist in these turbulent times without losing any competent specialists. The development of new drugs was able to continue. By the end of the 2000s, the institute had developed and launched 38 medicinal products of various types. Cooperation with various existing and newly established pharmaceutical companies was actively expanded.

The new chapter in the development of the Russian SID&GP

In 2014, the State Institute for Drugs and Good Practices (SID&GP) was given its current name. The institution was commissioned by the Minpromtorg (Russian Ministry of Industry and Trade) to carry out GMP inspections. Shortly before this, the Russian GMP guidelines were established. This marked the beginning of a new chapter in Russian GMP (Good Manufacturing Practice). A team of GMP inspectors was quickly formed and carried out the first Russian GMP inspection of a foreign manufacturer in April 2016. Since then, thousands of GMP inspections have been carried out worldwide, giving the Russian GMP inspectorate a good reputation in the pharmaceutical industry both domestically and internationally. Dozens of GMP inspections are carried out every month - in Russia, throughout the Eurasian Economic Union and worldwide. During international GMP inspections, translators are used to translate inspection-related documents and interpreters specializing in the pharmaceutical sector are used to communicate with the Russian GMP inspectors and representatives of the inspected manufacturer. We at GMP-inspection.com look forward to supporting you with our many years of expertise as translators and interpreters for Russian, German and English.

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