Order No. 606 of the Ministry of Agrarian Policy validating the Regulation on good manufacturing practice (GMP) for veterinary drugs.

This Regulation establishes requirements for the manufacturing of veterinary preparations in Ukraine for trade on the internal market and for export, as well as veterinary preparations imported into Ukraine. Section II of this Regulation applies to the manufacturing of veterinary drugs, including their complete or incomplete production, as well as various processes of packaging or labeling. In addition, the Rules apply to all serial production of veterinary drugs, as well as the production of veterinary preparations for clinical investigation and research. Section III of applies to specific stages and processes of the manufacturing of veterinary drugs. It shall not apply to issues of labor protection, sanitary and environmental safety, which are determined by other normative and legal acts. This Regulation shall apply to veterinary manufacturers to certify compliance with the requirements of the proper industrial practice of veterinary medicines and to build a pharmaceutical quality system and the organization of good manufacturing practice (GMP) of veterinary drugs. Manufacturing business entity owner is required to produce veterinary drugs that meet the requirements of the registration dossier or information and data related to the veterinary medicinal product under study for clinical trials (as appropriate) and exclude risks to animal health associated with insufficient safety, quality or efficacy of veterinary medicinal products. Quality assurance is the main task of the management and requires the participation and responsibility of the personnel of various units of the manufacturer or company at all its levels, as well as suppliers and distributors. To do this, a properly functioning quality assurance system should be developed, including good manufacturing practices (GMP), quality control and risk management for quality. This system should be fully documented, and its effectiveness is controlled. All parts of the system must be adequately staffed by competent personnel, have sufficient number of relevant industrial and residential premises, equipment and technical equipment. The basic ideas of quality management, good manufacturing practice (GMP) and risk management for quality are interrelated and of paramount importance in the organization of the production of veterinary drugs. The basic principles of quality assurance, quality control and risk management for quality are described in this Regulation in order to emphasize their relevance and essential for the manufacturing and control of veterinary medicines.