Study On Production Quality Management Of Powder For Injection In LK In LK Company Based On TQM

Total Quality Management is a systematic management program in which all the staff and departments are involved, through the application of modern technology and management techniques, to control the production process and the relevant factors and develop the best products for the consumers. The quality is not controlled by analysis but process in which the products are made, so it is feasible and effective to introduce the TQM to the pharmaceutical production. Based on the theory of TQM, the thesis explores the management of quality control in the production of powder for injection in LK Company to find out the problems that affect the production management of powder for injection by investigating and analyzing the present situation in production of powder for injection.By a series of investigation and analysis, the following management plans for the production of powder for injection in LK Company can be made out:the organization framework and their duties, the framework of quality control management system, the operation management of quality guarantee system, the change control management, the number code of materials, in and out of storage, storage and release, confirmation and identification management, production and plan management, rejected products management, batch release, abnormal situation management, state marks management, materials balance, production environment management, the compile, check, approval, print, release, usage, damage and classification, code number, requirements for records of the documents. All these management plans can ensure the products of LK Company meet the requirements of EU cGMP and international standards. Meanwhile, the authorizer system is proposed to emphasize the improvement of quality control, the effectiveness of operation and the participation of the management level. Besides, it is also proposed that the parameter limits of quality control for the production. Furthermore, the fulfillment evaluation and sustainable development of the management plans on the production of the powder for rejection in LK Company are also explored and the plan for improvement is made.Finally, the weak points of TQM are figured out, and 6a is proposed for the process control in pharmaceutical production; meanwhile, the feasibility of 6σin process control in pharmaceutical production is analyzed in this thesis.By the implementation of the above program, the products of powder for injection can meet the requirements of EU cGMP and the international standards. LK pharmaceutical company in Shenzhen is the only one to have the EU cGMP certificate for the production of powder for injection, whose products have been sold to Europe and America and made a great profit.