Gmp – new requirements for the production of veterinary madicines in Ukraine
Journal Title: Біоресурси і природокористування [Biological Resources and Nature Management] - Year 2019, Vol 11, Issue 1
Abstract
In order to successfully introduce GMP into the production of veterinary medicines in Ukraine, the following algorithm was developed, which includes: approval of the legislative base, training of experts on GxP issues, informing manufacturers to clarify requirements. To implement the tasks, an analysis was conducted of Ukrainian and European directives and standards that regulate the requirements for the production of veterinary medicines. During the study, methods of synthesis and system analysis of regulatory documentation were used. To date, the Ministry of Agrarian Policy of Ukraine has approved the Licensing Conditions for conducting business activities for the production of veterinary medicines and the Regulation on the basic requirements for the production of veterinary medicines with the Rules of Good Manufacturing Practice. The licensing system is the first step in establishing requirements that are based on good practices, including the mandatory availability of the Site Master File, which is also part of the documentation that is necessary from the point of view of GMP production of veterinary medicines. Thus, the approval of the legislative base, the preparation of GxP examiners and the information of the manufacturer are prerequisites for certification of compliance with GMP requirements for the production of veterinary drugs in Ukraine.
Authors and Affiliations
Yu. M. Kosenko, I. V. Pavliuk, L. V. Kalynovska
Keywords
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- EP ID EP661207
- DOI 10.31548/bio2019.01.017
- Views 82
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