Research On Building Learning Organization For EU GMP Project Team Of Y Pharmaceutical Company

With the increasing requirements of CFDA on drug quality and people's demand for drug safety,the improvement of drug production quality is a permanent pursuit for all pharmaceutical enterprises.In China,some large pharmaceutical companies ranked at the top of the industry have been trying for the EU GMP certification and the US FDA certification to meet the drug quality criteria of developed countries,to make the drug quality control ability reaching the leading level of the industry,to improve the competitiveness of enterprises and to enter the international market.The requirements on quality control ability are different for different drug dosage forms,among which sterile freeze-dried powder injection is the most demanding for quality control ability.In domestic only a few of enterprises obtained EU GMP on sterile freeze-dried powder injection.Y pharmaceutical company is one of the top 100 pharmaceutical industry companies in China,listed on the A-share main board market.In 2014,it began to prepare the EU GMP certification on sterile freeze-dried powder injection and established the EU certification project team.Four years later,the project progress didn't meet the expectation.After the questionnaire survey and interview of the project team members,the author concluded that the obstacles encountered in the project progress were ostensibly the project team members' limited knowledge of quality control,and the proposed solution was always unable to meet the EU GMP criteria,but the root cause was the organization form of project team.Based on the theory of "The Fifth Discipline" by Peter·Senge,the author conducts a research on building learning organization for EU project team.The organization culture development is carried out from five aspects,building the common vision,team learning,mental model,self-transcendence and systematic thinking.Construct the supporting measures from the aspects of horizontal organizational structure,learning resource platform building,learning mechanism,performance appraisal and incentive system,etc.In this paper,based on the actual situation of the existing problems of EUproject team,technical problems are solved by means of organizational reform.Through the two-wheel drive of system and culture of learning organizaiton,each member has the motivation,direction and resources to make self-learning.Through the knowledge sharing mechanism achieves the goal of team learning,and improves the technical level of the team.