Issues in revising the Code for quality management of drug manufacture (2010)

The revised Code for quality management of drug manufacture (2010) is further closer to the international standards. It is helpful to improve the medicine quality of China and to enter the international market. Provides some ideas and suggestions on the issues possibly occurred in implementation of the code such as cleanness classes, occupied conditions, testing point minimum sample amount, static pressure difference between different cleanliness classes, standby operating conditions, etc.