Quality management

The FGBI Federal Center for Animal Health (FGBI ARRIAH) with a branch in the Republic of Crimea is responsible for timely development and implementation of effective technologies and new veterinary medicinal products (vaccines, diagnostic kits), it constantly raises the professional level of the staff, is involved into comprehensive activities related to the surveillance of dangerous and highly dangerous animal diseases, disease risk and disease spread analysis, disease diagnostics, epidemic and immunological monitoring, as well as in development of disease prevention and eradication programs.

The institution endeavors to plan, develop and introduce new technologies in a timely and high-quality manner and master the production of the most demanded types of products and expand its capacities in veterinary service rendering.

The activities are compliant with the interstate standards (identical to international) GOST R ISO 9001-2015 (ISO 9001:2015), GOST ISO/IEC 17025-2009 (ISO/IEC 17025:2005) and the national standard (identical to the EU GMP rules) GOST R 52249-2009 Organization of the manufacture and quality control of medicinal products (GMP).

The quality management system (QMS) governing the development, manufacture, preclinical and clinical trials and control of veterinary medicinal products, biological and diagnostic tests, veterinary activities, has been in place in the FGBI ARRIAH since 2006 and is certified by annual inspections of Authorized Quality System Certification Agencies.

At the Russian Quality Assembly held on September 22, 2006 ( Moscow) the Director of the Programme for Global Quality Promotion, established by the Center for Marketing and Management (Geneva, Switzerland), awarded the FGBI ARRIAH with the Diploma and Gold Certificate of Quality.

The objectives of the Institution quality management system are aimed at: enhancing customer and staff satisfaction through continuous improvement of the quality of products and services provided; increasing the competitiveness of the company in domestic and foreign markets.

The QMS documents all types of activities of the Institution, and is based on research and development (R&D), which include: the development of new products (vaccines, diagnostic kits) and new services through the development of methods and measures to control diseases of animals and birds; continuous monitoring of the epidemic situation in the country and in the world, with the purpose of taking timely actions to ensure animal disease freedom of the country.

QMS is based on a process approach and includes the following quality system documents:

quality policy;
quality manual;
process flowchart;
organization standards (STOs);
standard operating procedures (SOPs), instructions;
regulatory and legislative documents.

Over a ten-year period, the Quality Management System of the Institution has been successfully re-certified.

Certificate of conformity GOST R 52249-2009 No.07.RU.01.21.2018, issued by OOO "VNIISERT"
Certificate of GMP compliance No.111/2019/GMP, issued by the Republic of Bulgaria
Report on GMP compliance No.GMP-46/21, issued by the Rosselkhoznadzor

The brand of FGBI ARRIAH is known both in Russia and abroad.

Further improvement of the Institution's activities in quality assurance is aimed at the constant maintenance of the operative QMS with mandatory implementation of good manufacturing practice (GMP); the introduction of elements of a quality assurance system based on Good Laboratory Practice principles (GLP).