Research On Quality Management Of Product Technology Transfer Of SA Pharma Company

As the global best-sellers of prescription drugs go off patent and the launch of the generic drugs consistency evaluation in China,the multinational pharmaceutical companies have accelerated their localization strategy and in the future,more and more localized production of drugs will be realized through technology transfer project,which would provide good opportunity for domestic biopharmaceutical industry to develop.The quality of technology transfer project is has a direct bearing not only on the product delivery and also on the health and safety of the people.Our domestic biopharmaceutical industry has developed GMP standard during several decades,but the study is quite rare on the way to address project quality management and reduce project quality risks.Therefore,the study on quality management of technology transfer project meeting international standard is quite necessary and has great significance.This paper focus on “the project quality management of technology transfer project of SA pharma” and states below points: the first is introducing the theory on quality management,project quality management and the study status of foreign and domestic project quality management.Secondly,specifying the methods of project quality risk management and Lean quality management based on the specialty of biopharmaceutical technology transfer project.Thirdly,introducing the technology transfer project background of SA pharma and putting forward quality management problems facing this project.Fourthly,conducting several case studies on quality planning,quality assurance and quality control in this project.Lastly,summarizing advanced quality management experiences in this project as to provide reference to similar project in China.