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Quality Control Analysis Of Pharmaceutical Tablet

Posted on:2012-04-03Degree:MasterType:Thesis
Country:ChinaCandidate:Y WangFull Text:PDF
GTID:2219330368979640Subject:Business Administration
Abstract/Summary:PDF Full Text Request
Continuous progress of science and technology, resulting in increasing standards of living, also with the requirements of industrial products constantly change. To meet people's needs,product quality improvement is imperative. With total quality management (TQC) mode of operation and management methods have emerged, from the 1960s in a few years of practice, the continuous development and improvement, GMP has become the most effective means one which achieve the product quality management. In today's industry. China TQC promotion and popularization of the product in the country greatly improved the overall quality and enhance the competitiveness of products, to speed up China into the international market in the pace of competition, to promote the further deepening of China's reform and opening up.To carry out a comprehensive management process to enhance product quality, China's pharmaceutical industry has become a top priority to enhance the quality of the field. Drugs is a special commodity, it is related to citizens' health and safety of drugs using, drug quality can not be ignored to the extent. From the beginning of China's 80 years since the implementation of GMP management, GMP has become a normative quality management regulations of pharmaceutical production.The 2010 version of this year the promulgation and implementation of the new GMP,more reflects of our GMP journey is gradually improving, more scientific and international. Pharmaceutical companies in the implementation process of GMP to ensure quality of medicines will become more standardized, and gradually improve business competitiveness, and international standards.However, the 21st century, In my country many injury events and adverse events that aroused the concern of the community and awareness of pharmaceutical companies. In the drug manufacturing process, GMP standards is only the foundation to ensure product quality. How drug quality in the manufacturing process to achieve effective quality control and risk prevention,the majority of pharmaceutical companies expect to seek countermeasures.This paper researches the quality control of pharmaceutical tablets. Select the most widely used entry point for drugs from the number of drugs in dosage forms of tablets, combine total quality manageability and manufacturing practices, study deeply about quality control strategy for the tablet .Paper first describes the current management of our country to carry out the background and status of TQC and GMP, and defines the ideas and content .On this basis, through the special pharmaceutical products in tablet dosage form analysis to determine the quality standards of the tablet control points.In the tablet under the control requirements of quality standards, this article focuses on the generation of quality control standards to identify factors, and uses a variety of TQC management tools, combines with the measured data, demonstrates the mechanism of action to the factors.Tablet product quality control strategy is the core of this article. Based on the factors affecting the identification, Targeted select the effective control strategies . From the correct implementation of laws and regulations, comprehensive production quality control management and promotion of early warning of risk control, propose a set of relatively strict quality control policy.Tablets in the pharmaceutical dosage form is the most widely used, also is the largest share of the dosage form in solid dosage formulations. In this paper, tablet quality control analysis and application of exploration, hope that other pharmaceutical companies for solid dosage formulations and similar quality control can learn from experiences.China's pharmaceutical quality management with the implementation of the new GMP is more standardized and upgrade requirements. To reduce the injury event, to reduce quality problems,to protect drug safety and people's health, drug quality control studies, to enrich our pharmaceutical companies to improve the quality of medicines and reduce the social harm, are of great practical value and strategic significance .
Keywords/Search Tags:Pharmaceutical companies, Tablet, TQC(Total Quality Control), GMP(Good Manufacturing Practice), Quality control strategy
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