Goy A. Development and implementation of a universal model of production of parenteral drugs on the principles of project management

The thesis presents a theoretical and experimental study on the establishment of modern pharmaceutical production of injection medicines in ampoules, vials and cartridges in accordance with international requirements for pharmaceutical practice and principles of project management, general conclusions were formulated as a result. Were specified conceptual provisions and project management of technological processes in pharmaceutical manufacturing of parenteral dosage forms of world-class industrial pharmacy. The tendencies of high parenteral drugs development and their industrial application in the modern pharmaceutical production were analyzed. It was established that the effective management of pharmaceutical development of injectable dosage forms should take into account the existing concepts of construction and best practice of efficient commission of modern industrial projects and effective models of pharm engineering in order to modernize. Research substantiates project management simulation of industrial production of parenteral drugs. Based on the theoretical generalization and system analysis was developed and implemented an innovative project - a universal integrated model of pharmaceutical production cycle of parenteral drugs according to ICH. On the basis of conceptual framework and methodological approaches and principles of project management of aseptic production of high parenteral drugs in vials, ampoules and cartridges, was developed and put into industrial production the innovative project "Universal integrated model of pharmaceutical production of parenteral drugs»© related to the field of industrial pharmacy and which discloses structure and technological complex, algorithms of technological processes of continuous aseptic production of parenteral dosage forms, realizes management of commercialization of innovative design of production lines and production facilities of aseptic production. The model reproduces the program cycle advanced pharmaceutical production of parenteral dosage forms involving three manufacturing sites and covers all technological stages of industrial manufacturing operations of injectable dosage forms in ampoules, vials and cartridges. The concept of model construction includes multifunctional use of technological equipment and production lines to ensure the continuity, efficiency, technological efficiency and adequate quality of aseptic production, quality and safety of intravenous dosage forms in ampoules, vials and cartridges, which are the finished products. The model provides time reducing, rational cycle time, costs reducing, proper quality of pharmaceutical product, sterility according to SAL requirements (1: 1 million), prevents the risk of cross contamination. Starting theses for development of innovative project "Universal integrated model of pharmaceutical production of parenteral drugs» © were guidelines GMP (COMMISSION DIRECTIVE 2003/94 / EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human); Guidance Ministry of Healthcare of Ukraine 42-4.0: 2008 Medicines. Good manufacturing practices; ICH Q10. Innovative project has following differences and advantages: universality (from concept to industrial application); versatility; multi nomenclature usage (advantage is the possible application to different groups of pharmaceuticals, while the classical approach to the aseptic production requires separate manufacturing sites); flexibility (the ability to switch cell production lines to increase the volume of the batch from 10 to 1000 liters); providing quality assurance of pharmaceutical products; mobility and speed of industrial application cycle for parenteral dosage forms in ampoules, vials and cartridges; efficiency and return on investment of the project. Efficiency of innovativeproject is confirmed by pharmacoeconomic parameters of pharmaceutical production. The versatility, flexibility and efficiency of the model are confirmed by pharmaco-technological indicators of the quality of pharmaceutical products - parenteral dosage forms in ampoules, vials and cartridges based on the results of experimental studies. Experimentally confirmed the efficiency of providing of universal integrated model cycle of pharmaceutical production of parenteral drugs according to ICH.