| Pharmaceutical Inspection is the Food and Drug administration according to law, inspection units inspected in the pharmaceutical, medical devices research, production, management, use of the activities carried out to determine their countries to develop legislation and regulatory compliance with respect to the process. Level pharmaceutical quality management system for inspection bodies to ensure drug quality has a major influence.The current simple management mechanism or government agency established by ISO quality management system can not meet the demand of professional management of pharmaceutical inspection, it is difficult to meet the in-depth inspection of the actual drugs, to ensure the working part of controlled risk. Promote China’s pharmaceutical inspection institution level quality management system with international standards, and approved, with the overall national units to join the international cooperative organizations to check medicines, it is an important strategy for China Food and Drug Administration has been pushing.In this study, the participation of WHO author of China Pharmaceutical Inspectorate quality management system assessment, for example, restricting China’s pharmaceutical inspection institutions to join international organizations and Drug Inspection Cooperation constraints and measures to be taken to improve the analysis from the perspective of the quality system. The first chapter describes the Pharmaceutical Inspection Cooperation Scheme to apply to join the Member States of the Organization of quality system requirements, World Health Organization to assess the quality of China’s pharmaceutical inspection problems exposed, and then study the advanced countries and some international organizations in the drug worth checking the quality system construction learn from the advanced experience. The second chapter analyzes the current situation of drug testing quality management system construction in China, compared to WHO assessment highlights issues, analysis of Chinese Pharmaceutical Inspection quality system key issues in line with international standards and the underlying causes. Third chapter reference part international advanced national and the Organization in Pharmaceutical Inspection quality management system construction aspects of advanced experience, to national General drug Pharmaceutical Inspection sector led started levels drug check institutions of collaborative management reform for based, proposed established unification of check system, and promoted Pharmaceutical Inspection institutions functions change and check work strategy adjustment, and advance Pharmaceutical Inspection information integrated shared and utilization, and strengthening check member team construction exploration, recommends, promote China Pharmaceutical Inspection Quality Management System fulfill international standards earlier, ability to improve drug quality and safety guarantee, protecting people’s safety. |
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