Pyrogen Control And Improvement In Pharmaceutical Production Of Company X

As people pay m ore attention to medical and health undertakings and strengthen supervision to m edicine manufacturing from country recently, more and m ore pharmaceutical production quality problems have been h ighlighted. There are many controls within the p harmaceutical manufacturing process and final products management. Pyrogen must be controlled in the pharmaceutical manufacturing process and it is also one of the important items of medicine quality inspection. Project Quality Management is the m anaging process to a ssure the customer's quality requirements within the field of Project Management. T product can be widely used in medicine and cosmetics industries, this thesis analyze the pyrogen control impact factors in quality management to improve the pyrogen control m anagement level. Product quality can be improved and market competency can be enhanced after im provement. Stability and sustainability of product quality can be realized after continuous improvement.This thesis describes the background of finding pyrogen issue in medicine firstly. In order to get the probable root cause, this program use fishbone diagram and risk analysis tools for analyzing. The whole pr oject utilize leading, organization, staff, plan and control approaches to benefit the product's quality plan, quality control and quality assurance. This thesis takes the whole T product manufacturing process in a X company of one city as an exam ple. The thesis analyzes the production process characteristics and technology characteristic s in order to develop the optim ization solution for pyrogen control im provement. As consideration of the technology characteristics of microbial strains fermentation and adsorption filtration, this research uses characteristics of fermentation strains, fermentation temperature and adsorption filtration technology as criti cal control indicators. Th is study p lans to seek the relationship between process control and product quality. Base on the study of process parameter optimization and technology im provement, the output can promote the pharmaceutical production control and contribute to improvement solutions in pyrogen quality control. The p roject team can ut ilize related program management theory combined with products result for summ arization, discussion, r oot causing and the action plan's for mulation. Pyrogen quality control and products' market competitiveness can be also improved base on this research.