Study On Six Sigma In Quality Evaluation Of The Tablet Production Site Change

As a special commodity, the quality of drugs is closely related to life of patients. With the enhancing risk awareness of product quality, especially the implementation of Good Manufacturing Practice in 2010, pharmaceutical enterprises increase investment in many aspects. In order to improve the product quality step by step, not only the facilities were improved, but also a perfect quality system was constructed. In addtion, an advanced quality management method for drug quality control was introduced at the same time.The production process of tablet with a lot of controlling items is very complex, which can be influenced by many factors such as personnel, equipment and environment. While, the uniformity and stability of production are the important goals in manufacturing of tablet preparations, which not only need the perfect quality system, pharmaceutical plant and advanced equipment, excellent pharmaceutical talents, but also need effective quality management methods. The manufacturers’ confusion is how to effectively evaluate the uniform product quality.This study used six sigma management theory and statistical process control technology to evaluate the quality control index of same product, which was prepared at six months or one year before and after the transfer of tablet production site change. First, to get the result of key quality index of each product, several quality indexes were analyzed and evaluated separately, such as the hardness index of metronidazole tabletsand roxithromycin dispersion tablets, the content index of metformin hydrochloride sustained-release tablets and so on. Then, according to the results of analysis and evaluation, the corresponding quality control index was evaluted by comparing the degree and ability to influence the product quality stability and production process. Next, a formula was designed according to the relationship of quality index test results and product quality. Finally, quality tools such as comprehensive value utilization control chart, which was achieved after evaluation, can be used to comprehensively analyze the product quality control. Furthermore, this result can provide the reference for the improvement of future production quality control process by comparsion the gaps and deficiencies in quality control before and after the production site change. At the same time, these quality evaluation methods can be used as references for other quality evaluation work.