Objective: To provide the specific ideas for Beijing drug regulatory department to formulate and improve the targeted regulatory measures

and provide technical basis for pharmaceutical enterprises to carry out the 2010 revision of Good Manufacturing Practice (GMP) more normally. Method: The defective items of 108 drug manufacturers in the new version of GMP certification inspection from Beijing during the period of Jan. 2015-Jun. 2016 were analyzed through frequency distribution method. Result: A total of 1 063 defective items had been found in 108 companies

and most of them were distributed in quality control and quality guarantee

document management and equipment

which were accounted for 24.37%

19.85% and 15.99%.The main issues reflected that the management of the quality control laboratory was not standardized;the file content was not accurate and not clear and not complete;equipment and instruments status identification was not in conformity with the requirements

etc. Conclusion: Drug regulatory department should formulate corresponding regulation measures and strengthen supervision.Pharmaceutical enterprises should formulate corresponding solutions for common defects project

strengthen internal management

make specific training plan

increase the intensity of training

promote the implementation of the new version of GMP.