Quality Risk Management In The Northeast Pharmaceutical Factory Application

Pharmaceutical manufacturing industry in the pharmaceutical production process quality control and management of the main in accordance with the "Drug Manufacturing Practice" (GMP) throughout, but with social development and a variety of adverse drug reactions to the emergence of drug administration and the industry more concerned about the quality of the management process of risk management, how to manufacture minimize the risk of the process is to introduce a new concept, occupied a very prominent position, plays an active role is a GMP management of the useful and necessary complement , is the protection of its drugs in the lack of focus on safety to be improved. Based on the pharmaceutical production and quality management business situation and needs analysis, process management solution, which leads to the concept of quality risk management. Through a detailed analysis of the quality of risk management, summed up the process of pharmaceutical production quality control problems and the introduction of quality risk management necessary. Management of the GMP process reengineering in order, through the terms of the ICH-Q9 and detailed understanding of management methods, the use of risk management tools in the Northeast Pharmaceutical quality management system of six major systems: organization and personnel systems, plant and facilities equipment systems, production systems, material systems, laboratory control systems, quality assurance system of control of one by one. And from 2005 plan and the implementation of HACCP management system, the results from the perspective of management in recent years and achieved good effects of risk control, to achieve the desired purpose. Full implementation of the entire system of quality risk management played a role in promoting.In this paper, the quality management system of quality risk management as the main object of study, to explore the quality of risk management and GMP quality system elements of the other relationships to explore the production process management in Northeast Pharmaceutical risk management and focus the need to find quality risk management objectives, thus promoting the production of quality risk management process carried out. In this paper, project management, process management, statistics, ICH-Q9 guidelines, GMP articles, ISO9000 standard theories and analysis methods, mainly in the pharmaceutical industry quality control of the situation analysis, needs analysis, solutions, management research in areas such as process analysis, focusing on ICH-Q9 terms and applied statistics in the Northeast Pharmaceutical quality management tools for risk management elements into the application and evaluation of several aspects. Main results are:1. A drug manufacturer to analyze the quality of management of the status quo, especially in GMP certified pharmaceutical industry quality management problems in the pharmaceutical enterprise quality management needs analysis, the method from the continuous improvement in the quality of risk management leads to philosophy of continuous improvement approach combines total quality management theory, considered that today's pharmaceutical industry is facing a grim situation, and made the process of quality management solutions that reflect a more realistic quality of the management of the pharmaceutical industry the actual level and the weak links.2. The use of process reengineering method for quality process management process is described and carding six systems analyzed GMP focus on specific elements and principles of management, analysis of existing GMP quality management system, risk management, the lack of content, introduces the risk of drugs management procedures and tools.3. On the management of ICH-Q9 detailed description of the contents of a detailed analysis of risk management in GMP quality management system of space and potential opportunities. Northeast Pharmaceutical application of quality risk management to develop statistical tools for a product of the HACCP plan, HACCP plan through analysis of critical control points and critical limits, and work out the frequency of the monitoring program results, verification of corrective measures such as continuous improvement process .4. Through the HACCP System and HACCP program implementation, the quality of the Northeast Pharmaceutical risk management applications to evaluate the importance of the drawn HACCP management to arrive at the importance of quality management wind direction, there are other existing inadequate and future development.The innovation of this paper is: (1) Northeast Pharmaceutical GMP quality management system to sort out proper risk management, more comprehensive taking into account the various elements of the pharmaceutical production process; (2) Quality Risk Management Case Study When using the statistical management Gongju HACCP, a product of the Northeast Pharmaceutical entire production process of the hazard analysis of the whole and Kongzhi ensure the production of the whole process Guanjianjiankong played a fundamental role of quality risk management, risk control the production quality process.