Legal-legal basis of improvement of continuing education staff enterprises industrial pharmacy. P a r t I. Draft Regulation on certification, licensing and certification of personnel pharmaceutical industry enterprises
Journal Title: Фармацевтичний журнал - Year 2014, Vol 3, Issue 3
Abstract
Good manufacturing practice requirements , combine to provide a system efficiency of drugs in outstanding quality depends on the human capacity. System of product quality, the appropriate level of staff should be fully documented and its effectiveness – controlled. Thus, all components of the system, its subsystems, components should properly be provided by qualified personnel. Each employee should clearly understand individual responsibility, which should be documented . Level of professional competence should be subordinate appropriate certificate universities III–IV accreditation levels. In Ukraine there is still such criteria are not normalized to the staff. The aim of the work was the creation , development and approval of the draft resolution of the Cabinet of Ministers of Ukraine and the Regulations on the licensing, certification of enterprises for the production of medicines. Studies were conducted on the basis of a retrospective analysis methods of the current state of postgraduate education staff training, retraining and certification pharma companies. The proposed draft resolution of the Cabinet of Ministers of Ukraine regarding the Regulation on licensing and certification training companies Industrial Pharmacy provides a basis to eliminate obstacles to the implementation of the constitutional right to post-graduate education and improvement of personnel of the enterprises of the pharmaceutical industry. Proposed a draft resolution of the Cabinet of Ministers «Regulations on the licensing and certification of professional level staff in the production of medicines». Decision of the Government of Ukraine can end continuation of heated discussions regarding implementation of permanent improvements and postgraduate certification of personnel in the field of medicines and pharmaceutical activities in Ukraine.
Authors and Affiliations
Yu. V. Voronenko, M. S. Ponomarenko, O. S. Soloviov, V. P. Chernyh, V. M. Tolochko
Keywords
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