In 2016 the FGBI “Federal Centre for Animal Health” provided scientific support for the works associated with infectious virus disease monitoring, assessment of risks of such disease introduction and spread as well as their prevention, eradication and measures taken for animal health and environment protection as a part of the Rosselkhoznadzor activities aimed at control and ensuring the biological and food safety of the Russian Federation. Research activities were aimed at development of effective methods and tools for livestock disease diagnosis, prevention and treatment and their introduction into production as well as at improvement of existing and new technologies for tools of protection against highly dangerous and economically significant animal and avian diseases.
The following laboratory tests were carried out in the framework of research performed under Government tasks in 2016:
The Laboratory for epidemiology and monitoring performed more than 75 thousand serological tests for currently significant avian infectious diseases and provided veterinarians of commercial poultry farms with recommendations and scientific and consultative support.
The Reference Laboratory for foot-and-mouth disease diagnosis carried out 858,610 tests of livestock sera in 2016 as a part of the Rosselkhoznadzor’s activities for ensuring compliance with the WTO SPS Agreement following the Russia’s accession to the WTO. A total of 26,193 tests of livestock sera from 51 regions were carried out to confirm absence of FMD virus circulation in naturally susceptible animals in order for Russia to be officially recognized by the OIE as FMD free at the international level. The test results confirmed FMD-free status of the said regions.
The Reference Laboratory for African swine fever performed investigations according to the following Government tasks: development of new test-systems for rotavirus infections, ASF, maintenance and replenishment of the All-Russian Collection of Cell Cultures, Virus Strains, Microbes and Mycopathogens, assessment of epidemic status of the RF regions and development of contagious and highly dangerous animal disease surveillance programmes for 2016 (FMD, PPR, CSF, contagious bovine pleuropneumonia).
The FGBI “ARRIAH” Testing Centre performed 9,569 tests under the Plan on official monitoring of food product quality and safety, 332 (3.2%) out of them were positive.
In July 2016 the FGBI “ARRIAH” successfully passed scheduled inspection of the Laboratory for Chemical Analysis for its proficiency and compliance with international standard GOST ISO/IEC 17025-2005 carried out by Slovak National Accreditation Service (SNAS).
In the framework of the official epidemiological monitoring the FGBI “ARRIAH” experts organized a scientific mission to the lake of Ubsu-Nur, Republic of Tyva, in 2016 where they isolated Н5N8 avian influenza virus from dead birds.
The FGBI “ARRIAH” experts monitored the epidemic situation on the OIE notifiable infectious diseases in the country and in the world (daily, weekly, monthly half-yearly and yearly information) and provided the Rosselkhoznadzor with the said data.
In 2016 the FGBI “ARRIAH” Laboratories carried out more than 50 investigations in biological test systems under Research Programmes and Governmental Tasks in its own animal holding facilities. The investigations included bioassays, development of pilot vaccines for animals against foot-and-mouth disease, lumpy skin disease, avian influenza, avian infectious rhinitis, infectious bursal disease, avian ornithobacteriosis as well as works on microorganism strain depositing and reconstitution of their activity.
The FGBI “ARRIAH” Department for Biological and Technological Control performed quality control of 427 batches of veterinary preparations including 37 batches of inactivated and 91 batches of live vaccines for avian disease prevention, 78 batches of inactivated vaccines for cattle and porcine disease prevention, 20 batches of live vaccines for small ruminant disease prevention, 75 batches of diagnostica, 21 batches of anti-parasite preparations and disinfectants and 84 batches of antibiotics in 2016.
The FGBI “ARRIAH” main production activities were focused on diagnostic test-system and vaccine manufacturing in 2016. A total of 2,824,097.27 ths doses of mono- and poly-vaccines (64 types of vaccines), 9,855 test kits (22 types), 100,088 litres of antimicrobial preparations (6 types) for diagnostic and preventive purposes.
On November 14, 2016 scheduled on-site inspection of the FGBI “ARRIAH” was carried out on the basis of the Order of Deputy Head of the Rosselkhoznadzor Territorial Administration for the Vladimir Oblast No.02/859 of October 12, 2016. No violations were detected during the said inspection. The said license holder complies with licensing requirements for pharmaceutical activities in the field of veterinary drug circulation.
High quality of developed and produced vaccines and diagnostic test-systems is annually confirmed at various exhibitions, competitions and other events. As a result of achievements in investigations and developments introduced into production the Centre was awarded the Diploma of the VIV MEA 2016, Abu Dhabi, U.A.E., for the active participation and round table on currently significant aspects in Abu Dhabi, U.A.E. in February, 2016.
At the Golden Autumn 2016 Russian Agricultural Exhibition the Centre was awarded by Gold Medals for development and production of associated emulsion inactivated vaccine against bovine para-influenza-3, infectious rhinotracheitis and viral diarrhea and emulsion inactivated vaccine against porcine actinobaccillus pleuropneumonia as well as Silver Medal for development and production of MARIVAC 1+3 viral vaccine against Marek’s disease.
On January 11, 2016 the Federal Accreditation Service by its Order No. А-63 approved the scope of accreditation of the Laboratory for Food Product Safety of the FGBI “ARRIAH” branch in the Republic of Crimea and issued the accreditation certificate No. RA.RU.21AZh15 of January 11, 2016.
The Sanitary-Epidemiological Conclusion Certificate on compliance with sanitary and epidemiological rules and standards for works with III-IV Pathogenicity Group microorganisms was issued to all current laboratories of the FGBI “ARRIAH” branch in the Republic of Crimea on July 15, 2016.
In August 2016 the Laboratory for Food Product Safety of the FGBI “ARRIAH” branch in the Republic of Crimea was listed in the Common Register of Testing Laboratories of the Customs Union under the CU Technical Regulation No. 1784.
On November 1, 2016 the Expertise Report on procedure for proficiency confirmation (31 methods, 15 parameters) and expanding of accreditation scope (12 methods, 12 parameters) of the FGBI “ARRIAH” branch in the Republic of Crimea was signed (Case of Public Service No. 15626-GU of August 29, 2016; the expanded scope of accreditation was approved by the Order of the Federal Accreditation Service No. 9116 of November 15, 2016).
In March 2016 the authorized Body on certification of Integrated Management Systems, OOO “Vladimir-Test” confirmed the compliance of current Quality Management System of the FGBI “ARRIAH” including its branch in the Republic of Crimea with the requirements of new national standard RF GOST R ISO 9001-2015 (ISO 9001:2015) “Quality Management System. Requirements” and issued the conformity certificate No. ROSS.RU.FK91.К00037 valid up to March 30, 2019.
In September 2016 the authorized Body on certification, ОАО “VNIIS”, carried out inspection of current quality assurance system of the Centre for compliance with the requirements of GOST R 52249-2009 (GMP) “Good Manufacturing Practice for Medicinal Products” and confirmed validity of the conformity certificate No. GMPEU RU.001.N0025 for veterinary product manufacturing and quality control until September 17, 2018.
Press-office of the FGBI “ARRIAH”