The review provides available information on the inspection of manufacturers of veterinary medicines for compliance with the requirements of the Good Manufacturing Practice (GMP) which is carried out by specialists of the Inspection Body of the Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI”).

Inspection results

Foreign manufacturers

According to the register of conclusions, published on the Rosselkhoznadzor website 25.07.2025 [1], 3 conclusions on compliance with the GMP Rules requirements were issued. These conclusions were made for sites located in Hungary, Italy and China.

By the end of October, seven GMP-conclusions had expired, and four more will expire this year. According to Victoria Khlynovskaya, a leading specialist of the Inspection Body of the FSBI “VGNKI,” at a roundtable discussion held by the FSBI “VGNKI” [2], approximately 60 foreign manufacturers currently have GMP conclusions.

In accordance with the inspection schedule published on the VGNKI website 28.10.2025 [3], 6 inspections of manufacturers of veterinary medicinal products are planned by the end of 2025, which sites located in Israel, Spain, China, New Zealand and Switzerland.

This year, a reduction in the number of inspections is being observed, due to the geopolitical situation and the refusal of some European and American manufacturers to undergo inspections [2, 4].

According to Timur Chibilyaev, Executive Director of the National Veterinary Association [5], nearly two-thirds of foreign manufacturers have left the Russian market in recent years. Those that have continued to supply include companies from Belarus, France’s Ceva, Spain’s Hipra, Slovenia’s KRKA, Germany’s Neoterica, and several others.

Russian manufacturers

According to Maria Novikova, Director of the Veterinary Department of the Russian Ministry of Agriculture [4], there are currently 90 enterprises in the country producing veterinary medicines. Of these, 13% are state-owned enterprises; 87% are commercial organizations. Currently, 2,473 veterinary medicines are registered in the Russian Federation, of which 1,589 are domestically produced, including 369 immunobiological medicines.

According to EMEAT analysts [6], the production of vaccines and toxoids used in veterinary medicine is showing steady growth. Since 2020, the average annual growth rate has been 26%. By the end of 2024, vaccine production in Russia will reach a record high of 32 billion doses, which is 2.2 times more than in 2017 and 52%, or 11 billion doses, higher than the 2023 figure.

According to Anna Babushkina, Deputy Head of the Department for the Organization of State Veterinary Supervision of Rosselkhoznadzor [4], confirmation of licensees’ compliance with the EAEU GMP Rules [7] can now be carried out within the framework of licensing, including periodic confirmation of the manufacturer’s compliance with licensing requirements, in accordance with Russian legislation.

According to Victoria Khlynovskaya [2], 28 domestic manufacturers currently have GMP conclusions.

Past events and activities

In July-October of this year, several events and activities took place that might be of interest to manufacturers preparing for inspection.

In July, the public discussion of the Draft resolution of the EEC Council “On Amendments to the Rules of Good Manufacturing Practice of the Eurasian Economic Union” [8] was completed. The purpose of adopting the Draft resolution is to update the general requirements for the manufacture of sterile products (Annex No. 1 to the EAEU GMP Rules “Requirements for the Manufacture of Sterile Medicinal Products”) taking into account the best international experience and law enforcement practices of pharmaceutical inspectorates of Member States to ensure the quality of the production process of sterile products in order to promptly identify deviations in the production process, as a result of which the finished product will be recognized as substandard.

Updated Annex No. 1 to the EAEU GMP Rules will come into force two years after its official publication, according to Nadezhda Arkhipova, Deputy Head of the Department of Pharmaceutical Manufacturing Inspection at the FSI “SID & GP” [9].

In August, the PharmPRO community of drug manufacturers and suppliers held a free webinar “Registration Dossier in the Production of Medicines and GMP Inspection” [10]. In her speech, Deputy Director of the Department of Production Development and Registration of NPF Materia Medica Holding Irina Krasnova paid attention to typical non-conformities related to the dossier and problematic issues in the preparation of documentation at the stage of significant changes.

In September, the GхP Training Center held a seminar in Kaliningrad entitled “Risk Management for Technologists using Examples”, which was led by an international expert Aleksandr Aleksandrov [11].

In the same month, the X All-Russian GMP Conference was held in Moscow [12]. The conference was organized by the Ministry of Industry and Trade of Russia together with the FSI “SID & GP”. On the first day of the conference, authorized government bodies and industry associations held a panel session entitled “Common Market of Medicinal Products for Veterinary Use in the EAEU.” [4].

Anna Babushkina concluded her presentation by saying that from March 1, 2026, the Russian regulator will be able to begin conducting pharmaceutical inspections in accordance with the EAEU Rules with the issuance of GMP certificates (Appendix No. 26 to the Decision of the EEC Council of 21.01.2022 No. 1 “On the Rules for Regulating the Circulation of Veterinary Medicinal Products in the Customs Territory of the Eurasian Economic Union”) [13]. This is since by this date, amendments to the Federal Law of 12.04.2010 No. 61-FZ “On the Circulation of Medicines” [14], adopted by the Federal Law of 31.07.2025 No. 304-FZ “On Amendments to Certain Legislative Acts of the Russian Federation” [15], must come into force in the Russian Federation.

The Advisor to the Director of the FSBI “VGNKI” Danil Rudniaev drew the attention of manufacturers to the most frequently occurring non-compliances:

• During incoming control, the bioburden of the raw materials included in the composition of sterile medicinal products is not checked (enterprises rely on analysis certificates and analytical sheets provided by the supplier, but this is not enough).
• The number of reference samples of finished products is insufficient to permit the carrying out two occasions of the full analytical controls for all quality indicators (most often this is since samples are not stored for two occasions of the analytical control for the “sterility” indicator).
• Thermal mapping of warehouse premises is carried out without taking into account seasonality (it is necessary to conduct thermal mapping during the hottest and coldest periods of the year); loggers for routine monitoring are not installed based on the results of thermal mapping (for example, there is no explanation as to why loggers are not installed at the points where the highest temperatures are observed according to temperature mapping data).
• When qualifying equipment, tests are not carried out at operating parameters equal to the upper and lower permissible limits (usually this refers to OQ).
• Integrity testing of vials with sterile products is not carried out (not all enterprises have implemented appropriate control methods).
• Primary packaging of parenteral products is not inspected for the presence of sub-visible particles (in some cases, registration dossiers do not provide quality control for this indicator, but the pharmacopoeial article for dosage forms for parenteral use includes requirements that they must withstand tests for visible particles and sub-visible particles).
• No particle monitoring is carried out during assembly and adjustment of equipment in areas where sterile medicinal products are produced (particle monitoring should be carried out, including during commissioning and calibration on the filling machine).
• No control is carried out over the conformity of the information contained on printed materials for medicinal products intended for the Russian Federation (appropriate control, for example using a stencil or software, should be carried out upon receipt of printed materials from the printing house).
• Quality control/testing methods are not validated (and in case of using a pharmacopoeial method, it must be verified).
• Decontamination procedures for accidental spillages of liquids containing live microorganisms during the production of immunological medicinal products have not been validated (e.g., a procedure exists, but its effectiveness has not been validated, or the procedure has only been validated on a single microorganism that has not been identified as a worst-case microorganism).
• The routine process of aseptic filling of medicinal products is carried out by operators who have not participated in the Media Fill Test for more than a year (process simulation tests should be repeated twice a year per shift and process; however, the updated Appendix No. 1 to the EAEU GMP Rules, which will soon come into force [6], states that еach operator should participate in at least one successful APS annually).
• When performing aseptic operations, microbiological monitoring is not carried out by all the provided methods (using not only settle plates method, but also other methods). 

At the beginning of October, a “Register of Pharmaceutical Inspectors of the Veterinary Pharmaceutical Inspectorate of the Russian Federation” was posted on the Rosselkhoznadzor website [16].

In the same month, the VII International Conference “Medicinal Products Logistics” [17] was held in Moscow. Conference participants received the GDP Review 6 practical collected articles.

Among other topics, the Conference included several sessions related to ensuring the quality of medicinal products during their transportation by various modes of transport: “Validation of the Transport Route for Medicinal Products by Road,” “Audit of Validation and Verification Processes for the Transportation of Medicinal Products,” and “Characteristics of Organizing a Cold Chain from Asia.”

You can also read about the verification of the medicinal products transportation process here.

At the end of October, the International Specialized Exhibition “FeedVetGrain 2025” was held in Moscow, within the framework of which a round table of the FSBI “VGNKI” entitled “State Registration of Veterinary Medicinal Products and Prospects for the Development of the Feed Industry” was held. At this roundtable, Victoria Khlynovskaya gave a presentation on “Special Features of Inspecting Manufacturers of Veterinary Medicinal Products” [2].

Upcoming events and activities

In November, Moscow will host the leading international exhibition of equipment, raw materials and technologies for pharmaceutical production in Russia and the EAEU countries, Pharmtech & Ingredients 2025. On November 27, the exhibition will host a round table dedicated to the veterinary medicines market as part of the business program – “ From Import Substitution to Technological Leadership: New Challenges for Russian Veterinary Pharmaceuticals” [18].

On December 9-12, the GхP Training Center will hold a “Validation Specialists Forum” [19] in Moscow. This will include theory, practice, and professional discussions on all aspects of qualification and validation to confirm proper production and distribution of medicinal products, with examples, algorithms, templates, and detailed discussions.

Manufacturers are encouraged to take an active part in GM(D)P-related events and activities and prepare more thoroughly for GMP inspections.

The material presented was prepared using data relevant to 30.10.2025. In case of new or additional data the article can be updated.

The Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed”, FSBI “VGNKI” is an institution authorized to conduct inspections of manufacturers of medicinal products for veterinary use manufactured outside the Russian Federation for compliance with the GMP Rules requirements

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