GMP – new requirements for the production of veterinary madicines in Ukraine

Abstract

At the current stage of the development of the veterinary pharmacy in Ukraine, the regulation of requirements to all stages of the life cycle of veterinary medicines (VM) is due to the establishment and implementation of national regulations of GMP.

The purpose of our studing was to develop a legislative framework for the introduction GMP in production of VM in the algorithm: the legal framework, ready experts from GхP, informing producers.

 In order to achieve the objectives, the analysis and grouping of Ukrainian and European directives and standards that regulate the requirements for the production of veterinary medicines were conducted.

To date, by Order No. 606 of 10.11.2017, the Ministry of Agrarian Policy and Food of Ukraine approved the Regulations and Rules of GMP.

However, the primary authorization document for the conduct of economic activity is a license. The Resolution of the Cabinet of Ministers of Ukraine dated October 3, 2018 No. 808 approved the Licensing conditions for conducting economic activities for the production of veterinary medicines, which are consistent with the requirements of GMP for veterinary medicines, as well as one of the obligatory documents is Site Master File. The analysis of the SMF identifies manufacturers of VM that do not meet the established requirements for production conditions, technological processes, quality control, implementation of the pharmaceutical quality system and personnel training. The next task is to prepare experts in the field of inspection for compliance with GMP requirements for veterinary medicines, so within three years, the experts in the sector of good practices of the National Agency of State Scientific-Research Control Institute of Veterinary Medicinal Products and Feed Additives take on the positive experience of certified PIC / S inspectors, participate in joint inspections on Compliance with GMP European Veterinary Products. Informing manufacturers of VM is also important in this GMP implementation strategy. Every year, starting from 2014, State Scientific-Research Control Institute of Veterinary Medicinal Products and Feed Additives and fodder supplements, with the support of the State Service of Ukraine for Food Safety and Consumer Protection hold on international conferences and seminars with the participation of European and American experts where highlighted the peculiarities of implementation and maintenance of GMP requirements.

Thus, the approval of the legislative framework, the preparation of experts on GxP and the clarification of new requirements for implementation of producers is a prerequisite for confirming the compliance of the GMP requirements of veterinary preparations in Ukraine.