| In 2010,the State Food and Drug Administration issued GMP(GMP),the regulations on the basis of the 1998 edition to make adjustments,mainly on the basis of reference to the drug production quality management standards such as the United States and EU countries.The new version of GMP for drug production and quality management have a clear demand further,the standard also had clear improvement,and requirements of domestic pharmaceutical enterprises in the implementation of the 2010 edition of GMP before the end of 2015,if not up to the 2010 version of the GMP requirements,enterprises will face the risk of suspend production for rectification or even cancel the drug production license.At present,many domestic pharmaceutical enterprises quality management system has not yet reached the requirements of GMP 2010 edition,for this reason,these enterprises need to solve the existing problems in the quality management system fundamentally,especially need to improve the existing quality management system,in order to fully meet the requirements of GMP 2010 edition.This paper takes M Pharmaceutical Co.Ltd as the research object,the company mainly according to GMP(GMP)and the global quality system of the company(GQS)for quality management,but there are some problems in quality management of the company's quality management system,and then put forward to solve the quality problems existing through the Countermeasures of establishing drug quality supervision system then,with the idea of project management,planning and management of the whole project.Quality management is a continuous process,M Pharmaceutical Co.Ltd.to the 2010 edition of GMP(GMP)and the global quality system of the company(GQS)as the basis,establish a set of perfect quality management system,prevent quality security risks from the source,the quality system of the company rose to a new level of quality management,so as to create a brand of M pharmaceuticals,drug quality,implementation of patient commitment. |
PDF Full Text Request