Research Of Drug Manufacturing Quality System Management Of SJZ Pharmaceutical Company

In this paper,taking SJZ pharmaceutical company as the research object,this company has passed EU GMP certification and American FDA certification for several times from 2010 year to now,its quality management system confirm to EU GMP and FDA CGMP requirements,but we also found many problems of several critical procedures in the process of quality management in daily operation,for example the problems of change control management,of deviation management,of personnel training management and of supplier management.Using risk management tools to analysis these procedures and find root cause of affecting these procedures management.Change control management is not completed,and the effect of change control management is not good,lack effective guidance of change control.The deviation that caused by personal equipment and raw material,all kinds of problems that caused by personal miss effective training,the problems rise in the process of suppliers management,from analyzing the root cause of these problems.According to root cause,we take effective corrected action and preventive action and take them into apart Then we get the research conclusion of this paper: 1.Revise the control change management procedure,for every change control,take effective and viable action protocol by the guidance of many EU and FDA regulation and all kinds of guidance.Each department should coordination,jointly participate in the discussion and decision making.2.Revise the deviation management procedure,reduce the frequency of deviation effectively,reduce the frequency of material loss and extending manufacturing time.3.Set up strict personnel training procedure and strictly implement,at the same time establish strict appraisal procedure,enhance people's sense of responsibility.4.Establish an effective supplier management procedure,effectively reduce the deviation of raw materials quality,fully guarantee the quality of raw materials.From revise these management procedures,so as to manage change more effectively and reduce the occurrence of deviation,improve the effectiveness of staff training,effectively manage compliers to ensure quality of raw materials,eliminate potential quality safety problems from the source,make the company up to a whole new level of quality management,fully guarantee the quality of products,maintain good company image of the brand value.