Research On Production Quality Management Of HY's Pharmaceutical Workshop

With the rapid development of China's pharmaceutical industry,pharmaceutical products are more and more rich,but there are many very serious medical accidents.Consequently,the problems of drug quality have once been pushed to the cusp.In the environment where the problems of drug quality are greatly concerned by the broad masses of people,the China' drug supervision and administration department has added multiple emphasis to the supervision of them.In the time of the implementation phase of China's Good Manufacturing Practice for Drugs(GMP,2010)(hereinafter referred to as the current version of GMP),related drug manufacturers' GMP certification work is also carried out in full swing.Drug production industry is facing a "big revolution." To seize the preparatory stage of current version of GMP certification,and back from the core unit of production,take the workshop as a breakthrough,re-examine the production quality management of pharmaceutical production enterprises,combined with the current version of GMP standards for rectification.Not only benefit the efficiency of the enterprise itself,but also show that the whole field of pharmaceutical production has attached much attention to the quality of pharmaceutical production,which is of great significance to enhance the overall quality of drugs.This paper takes the production quality management status of HY company's NO.1 workshop as a research object.It aims at improving the production quality management level of the workshop,and provides a theoretical reference for the preparation of its current GMP certification.Based on the overview of pharmaceutical production quality management,this paper analyzes the production quality management situation of HY factory in NO.1 workshop by using literature research,field investigation and empirical analysis,and finds out the existing problems.Version of the GMP related requirements,around the workshop process layout,clean level,software system,staff,quality review five aspects,put forward the corresponding improvement program,and finally draw the conclusion.