Research On Optimization Of Quality Management System Of Pharmaceutical Production Of Company A

The 21 st century is a century of quality.The quality of drugs is not only related to the technical level of the enterprise itself,but also to the quality management level of the enterprise.The key to ensure the quality of pharmaceutical industry is to establish the strategic position of quality management and the quality management level is one of the core competencies in the market competition.Through the investigation about some small and medium-sized pharmaceutical enterprise although has passed GMP certification,but there are still some problems of quality management of insufficient understanding and do not realize,there is no set up a system,the highly effective quality management system,covering the whole industry chain to obtain economic benefits to the enterprise to realize benign development form a constraint,so we need to discuss the series of problems of quality system optimization to create better economic benefits and social benefits and ensure national security.In this paper,the theory of quality management of pharmaceutical industry are expounded,combined with A company quality management status quo,analysis of its thinking,the application of comparative analysis,five factors analysis,literature review and research methods,such as online retrieval find some defects existing in the enterprise quality management system and the causes of quality problems,through purchases from supplier to the customer feedback process of deviation management,supplier management,staff training management,change management,etc.,using charts and data analysis of these problems,so as to find the root of the problems of the company quality management system,including the training effect of personnel quality consciousness is poor,poor make slight deviation gradually worse;Lack of review of quality management documents and periodic revisions resulting in imperfect quality management system documents;There is no effective internal audit system to restrain the managers,so that their production management can not keep pace with the rhythm;The enterprise informatization degree is not high,which leads to the ineffective monitoring of the production process and can not participate in the quality management of the remaining personnel to form a better assistant,etc.Then,put forward the concrete measures of improvement on the basis of the theory of total quality management(personnel,equipment,material,method,environment),such as PDCA circulation model for quality system for continuous improvement to ensure the GMP regulatory requirements in A company to get the real implementation,internal set up quality management system is feasible and effective.Finally,we get the conclusion of this paper:1.There are commonalities between different quality management concepts;2.Effectively reduce the deviation problem and deal with the problem of change;3.Effectively complete production management and quality management relying on internal audit.The continuous improvement of the quality management system and continuous improvement and long-term persistence need total involvement in the process,the introduction of advanced management concept to improve the quality management system for enterprise future development has the very vital significance.A pharmaceutical company need based on the new GMP to improve their own quality management system,in the daily management activities in the science to the implementation of the quality risk management,quality from the source to eliminate safety hidden trouble really make the company quality management level to a new level to build the brand,win public praise,not only realize the commitment to patients,more we need to fulfill their corporate social responsibility.Throughout hebei province in pharmaceutical enterprises,the company A as a medium-sized pharmaceutical production enterprise,the company in the process of steady development,needs throughout the drugs to strictly control the quality of the product life cycle,according to a series of problems in the process,pick out the strong representative problems to complete this topic research,research on quality management of A company and put forward solutions can for other quality management level is not high but would like to actively improve the quality management of some enterprises provide a good reference.