Research On Quality Improvement For The New Gmp Certification In SJ Pharmaceutical K Workshop

SJ pharmaceutical,with 60 years history,is one of the earliest pharmaceutical enterprise gain the national GMP certification.It is one of the earliest drug production enterprises with advanced technology in Heilongjiang Province.At present,brand SJ has abundant enjoy a high reputation both at home and abroad.With the implementation of the new version GMP,SJ pharmaceutical also faces passed the new GMP certification test.Based on the actual situation of SJ pharmaceutical,this paper makes a deep analysis and discussion on the problems existing in the quality improvement of K workshop oriented to the new GMP certification and puts forward the solution for each problem.In this paper,by analyzing the topic research background,the pharmaceutical industry development to clarify the meaning of K workshop for quality improvement;Through comparative analysis of the old and new version of GMP,this paper sums up the advantages of the new GMP.They are emphasizing dynamic management,highlighting the quality of risk management awareness and pay more attention to the whole process of production control.On the basis of this analysis,come to the conclusion that the most prominent problem of SJ pharmaceutical K workshop to meet the new GMP certification quality improvement is as follows: the quality management system is imperfection,the workshop layout is not reasonable,the existing equipment cannot satisfy the new GMP requirements.Then targeted propose solutions.Improving the quality management system by optimizing of organizations,new quality risk management,improving the classification of the change control management,new deviation management,to strengthen the management of supplier audit and evaluation and new product quality review analysis aspects.Improving the organization and clear responsibility,quality risk management consciousness,change control,deviation handling management,supplier management and product quality review analysis aspects.According to the basis of a plant reform,redesign the workshop layout and change the pattern of production line;Update some of the equipment and eliminate some of the equipment,at the same time to conduct a comprehensive upgrade to theenvironment system.Meanwhile,in order to ensure the smooth implementation of the solution,puts forward the safeguard measures from three aspects:respectively from the practical to do a good job of GMP training,cultivating the quality risk management consciousness,establish the respect such as everyone involved in GMP and redeem innovative management team thought to do a good job of raising the personnel quality level;From the optimized ERP information system and upgrade SJ production management platform to do a good job of improved information systems;From set up special fund reform and effectively control cost two aspects as the source of reconstruction funds security work.Desirable to provide certification of quality improvement scheme of reference to the enterprise has not yet adopted the new GMP certification,and provide feasible suggestions for daily quality management to company has passed the new edition of GMP certification.As well as pharmaceutical companies to further strengthen risk awareness of management and junior staff.