Study On Process Quality Improvement For Company B

The quality of the drug has a key impact on the health of the patients and development for the pharmaceutical enterprises.The drug quality crisis has led the government,the public and the pharmaceutical companies to pay special attention to the quality of drug production.China promulgated its "Good Manufacturing Practices"(GMP)according to foreign advanced concept of pharmaceutical management.By the implementation of GMP,the pharmaceutical companies which failed to meet the quality standards have been eliminated.The companies which passed the GMP certification have taken the opportunity to enhance their quality management level and the drug quality has been guaranteed.Company B,which focuses on the production of sterile drug,is one of the first batch enterprises through the GMP certification.With the development of enterprises,some problems in the production process begin to emerge,making the company’s complaints rate and the cost of products increased.This thesis focuses on the quality management problems in the process of production.In the first chapter,this thesis makes a brief introduction of B Company,and then described the content of this thesis.The second chapter introduces the theory of continuous improvement of production process which will quote in this thesis,as well as the quality management of pharmaceutical enterprises.The third chapter describes some problems existing in the current production process of B Company.This part introduces the characteristics of the company’s products and the monitoring measures of the production process and described the quality problems in the Key working procedure.In the fourth chapter,the production process is analyzed and the improvement measures are implemented from human,machine,material,method and environment.Aiming at the problem described in the third chapter,the fifth chapter describes the quality improvement of bag making process.In a survey of deviation,the problem is analyzed and the quality improvement measures are established by using statistical tools.In the sixth chapter,the process monitoring and improvement of filling process is described.The production process will be grasped more accurate by using statistical tools.In the last chapter,the improvement measures of packaging process are described.The effectiveness of packing inspection will strengthen and the directivity of the process improvement will be increased.All of the above measures are helpful to improve the quality control level of the production process.The research content of this thesis has a certain reference value for the quality improvement of the manufacturing process of pharmaceutical enterprises.