Portianko T. Development of tool and method of estimation of control of quality on a pharmaceutical enterprise

The walkthrough of domestic and foreign scientific and technical literature, and also certain estimation of experience of pharmaceutical enterprises, is conducted from the use of the management systems internalss (SMQ) which are built on the requirements of international standards. During realization of scientific researches over 100 sources were considered, part from which is sacred to fundamental theoretical positions, what internalss related to providing and to the competitiveness of pharmaceutical products in the conditions of quick-changing requirements of market environment, by the construction of computer-integrated control system and by concrete researches which was conducted lately in this industry. In dissertation research a ground is carried out and the mathematical model of estimation of quality and control efficiency which allows to perfect the normative providing due to introduction of ISMQ on a pharmaceutical enterprise is offered. The methods of estimation of effectiveness and permanent improvement of the productive system are offered on "Cherkassy-Pharma". Formed methods of estimation of efficiency of sampling test of quality of products, that allows to set of sphere of realization of control for the different values of his efficiency and set the different numeral indexes of control plans, taking into account requirements which characterize reliability of products, implementation of which is confirmed by experimental researches. It is set that the theoretical base of development of the normative providing of construction and use of ISMQ are forms of structural analysis of intercommunications of international standards of ISO of series 9000 and Options medications.