Advance of nitrosamine impurity inspection technology and drug administration
Genotoxic substances-nitrosamine impurity are one of the key inspection indicators for chemical drug quality control in recent years.The China,European and USA drug regulatory authorities present supervision strategies of nitrosamine impurities were studied,and the research advance of nitrosamine impurity inspection technology in each drug administration authority was analyzed.It was put forward that the regulatory scientific research on nitrosamine impurities must be strengthened,regulatory strategies based on risk assessment should be improved,regulatory strategies and standards coordination among drug regulatory authorities was supposed to be strengthened,the development of inspection technology ought to be accelerated,drug sampling and testing methods should be utilized to ensure the security of the pharmaceutical supply chain,so as to provide reference for chemical drug quality control in China.
NETL
NSTL
万方数据
