Kajdalova A. Development of the integrated control system of quality ISO 9001:2000/GMP at the pharmaceutical enterprise

The condition of introduction of control systems by quality at the domestic pharmaceutical enterprises is analysed. The comparative analysis of the international standard ISO 9001:2000 and rules GMP is made, the general attributes and differences are revealed. The basic methodical approaches to creation of the integrated control system by quality are certain, the algorithm of introduction of the integrated control system by quality ISO 9001:2000/GMP at the pharmaceutical enterprise is developed. It is developed organizational structure of the pharmaceutical enterprise, it is generated processes and their corresponding directions of activity at the pharmaceutical enterprise, it is developed process model of the pharmaceutical enterprise in conditions of the integrated control system by quality and it is developed a matrix of the responsibility for each process. Departments and the basic posts are certain, it is offered and is entered structure of a department of maintenance by quality, a department validation and certifications, a department of training of the personnel in conditions of introduction and functioning of the integrated control system by quality. The basic directions of improvement of the documentation in integrated control systems of quality at the pharmaceutical enterprise are certain. Necessity of management is proved by the documentation and the basic document of the integrated control system by quality – the Management on quality is developed. Technological processes of manufacture of medical products of the pharmaceutical enterprise «AIM» in conditions of the integrated control system are advanced by quality. The educational system of the pharmaceutical enterprise in conditions of the integrated control system is offered by quality; forms, methods and the maintenance of training