Analysis On The Status And Research On Improvement Countermeasures Of Pharmaceutical Quality Management System In S Pharmaceutical Company

Biotechnology is changing dramatically in several main therapeutic field,which mainly benefit from breakthrough progress made by genetics,molecular biology and biochemistry aspects in the past three decades.The development of genetics and molecular biology,(such as the completion of human genome sequencing confirmed)help find the pathogenesis of many diseases at the molecular level,promote the innovation of biological medicines,and finally the design of personalized medicine of biotechnology in the world.Recombinant DNA technology progress promoted the biological drugs(such as human growth factors,monoclonal antibodies and fusion protein)of the mass production.In addition,the analysis technology to improve the characteristics of the polymer(including proteins and nucleic acids)improves,which helps to screen and identify with complex structure and different new biological agents for the treatment of curative effect.Technology development lays a good foundation for the rapid development of biological medicine industry.Due to innovative biotech drugs launched and strong growth,biological pharmaceutical industry has become an increasingly important part in pharmaceutical industry.As a pioneer in gene pharmaceuticals,S Pharmaceutical Company is a leading domestic biopharmaceutical company,with the EU standard construction of the modern plant and the pursuit of compliance with GMP norms of high-quality products.The company constantly improves quality management,whose all products through domestic GMP certification and strive to adopt EU PIC/S GMP certification.It has established in line with the domestic Code for Quality Control of Pharmaceutical Production,the quality management system,but actually in the production process is still not effectively prevent the occurrence of quality problems,which is negative for the company’s long-term development.At the same time,problems meet by S Pharmaceutical Company in the pharmaceutical industry have a wide range of representation.S Pharmaceutical Company has passed the domestic GMP certification,but in the subsequent production it is unable to maintain a good quality management level and continuous improvement.In this way,it also hinders the rapid development of the pharmaceutical industry.This paper firstly introduces the relevant concept and quality management tools and methods of quality management system.Secondly it introduces the development situation,organizational structure,pharmaceutical production,quality objectives and organization,quality management system documents and regulations,quality management system resources,Quality management and other aspects of the formation of S Pharmaceutical Company.Thirdly,through deep analysis of the problems in S pharmaceutical company’s quality management system,and comprehensive research,I found problems in quality management system of S Pharmaceutical Company,use total quality management theory,PDCA cycle model and so on,and combined with the domestic GMP,current international applicable regulatory requirements to continuously improve and form a systematic improvement program for S pharmaceutical company quality management system.The protocol will make a positive effect on S Pharmaceutical company’s good operation,and ensure that the company can continue to supply safe,reliable drugs to customers.Also this paper will help the biopharmaceutical industry to improve the quality management level.