Reflection on Standardized Management of National Drug Standard in China / 中国药房

ABSTRACT

OBJECTIVE:To provide reference for standardized management of national drug standard in China.METHODS:Special inspections about the implementation of national drug standard were performed in pharmaceutical manufacturers of Deyang area.Based on the results of daily inspections,national drug standard was analyzed and discussed comprehensively.RESULTS:National drug standards were too many and diverse so that they influenced standardized management and implementation,which involved several aspects such as legality and seriousness of the management of drug standard,the conformity of relevant policy with drug standard,the standard of raw material and excipients,standardization of management approach for reference sample.CONCLUSION:Rigorous,complete and accurate national drug standards should be formulated,and relevant laws and regulations should be improved.Pharmaceutical enterprises can be urged to establish standardized drug standard file and to organize production and testing in accordance with national drug standard.