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Russian GMP-inspectorate. Five years of guarding quality

This year the Russian GMP inspectorate marks its 5th Anniversary. On 12 April 2016, the first overseas GMP inspection took place, in which 12 inspectors participated and inspected a KRKA site in Slovenia. In the first 5 years of its active and productive work, the Russian GMP Inspectorate has conducted more than 2390 inspections in 71 countries worldwide and 1861 certificated were granted.

During the five years of its work, the Russian GMP inspectorate has forged relationships with many foreign regulators in terms of exchanging perspectives, conducting joint training projects, participating in sectoral seminars and conferences. Today the inspectorate is receiving congratulatory letters, including from its foreign counterparts, among which, for example, are regulators from Bulgaria, Montenegro, China, Tunisia, Chile, Hungary, Bosnia and Herzegovina, and Cuba.

The Russian inspectorate to open to cooperation and has instituted a practice of inviting foreign regulators in the capacity of observes during inspections on sites. In autumn 2020, when, due to the pandemic, borders were closed, with the aim of ensuring the continuous supply of drugs to the Russian pharmaceutical market, FSI “SID & GP” inspectors in conjunction with colleagues from the Department of pharmaceutical and medical industry of the Russian Ministry of Industry and Trade have developed alternative methods of inspections in a remote mode. As of last year, more than 300 online inspections have been conducted, which prevented drug shortages in Russia.

“The modern Russian GMP Inspectorate – is an industry driver, active participant in key industry projects and initiator of joint international projects. – notes deputy head of the Russian GMP Inspectorate Director of FSI “SID & GP”, Vladislav Shestakov. – Each of our inspectors not only has real work experience at operating manufacturing sites, but also never stops in its development and knowledge acquisition. In order to conduct quality inspections it is imperative to stay abreast of the current world manufacturing standards, their relevant changes, know advanced technologies and novelties, changes in the Russian and Eurasian legislation and keep up-to-date with world tendencies and trends of the pharmaceutical industry.”

FSI “SID & GP” is expanding the scope of its accreditation with a perspective to render consulting services for drug distributors before licensing, and it also has personnel, who have completed training on inspections of testing laboratories for the conformity with the GLP requirements.

“Over the years of the joint work with the Department of pharmaceutical and medical industry development of the Russian Ministry of Industry and Trade, we were able to create an inspecting system that meets international requirements and standard. –explains Director of FSI “SID & GP Vladislav Shestakov. – Today our inspectors regularly participate in different international educational events that are organized by large pharmaceutical communities. Moreover, we ourselves are the organizers of a major GMP Conference, which, over the years of its work, has established itself as a platform for exchanging experiences and interdisciplinary discussions amongst leading Russian and international experts of the pharmaceutical industry”.

At the end of last year, Russia applied for the membership of PIC/S (Pharmaceutical Inspection Co-operation Scheme). Experts from the Department of pharmaceutical and medical industry development of the Ministry of industry and trade of the Russian Federation, FSI “SID & GP”, Federal Service for Surveillance in Healthcare (Roszdravnadzor) and the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation (FSBI “SCEEMP”) worked on the application. Joining the PIC/S would give Russian an opportunity to take part in working on advanced documents in the field of inspecting, participate in deliberations, discussions and develop recommendations on inspecting manufacturers of drugs for human use for conformity with good practices.