III. Analysis on pharmaceutical GMP inspection of different organizations

　　In terms of inspection content, there was certain difference in the inspection focus among different pharmaceutical GMP inspection agencies, but it was found in the analysis on the deficiencies identified in the observation inspections in 2016 that there were relatively more deficiencies in six aspects including Quality Control and Quality Assurance, Documentation Management, Equipment, Materials and Products, Verification and Qualification and Premises and Facilities. As for the number of deficiencies in the final inspection report,

EDQM and WHO proposed more deficiency data, averaging 20 deficiencies in each inspection. For each deficiency, the problems identified during the inspection have been described. After the finish of inspection, such problems have been organized for preparing final inspection report (usually a month). US FDA proposed relatively less deficiencies in the inspections, averaging 7 deficiencies in each inspection, and did not take all the problems identified during the inspection as final deficiencies. The inspectors proposed the final deficiencies after the judgment based on the problems identified in combination with the product risks, and notify the enterprises in written form (Table 483) when holding the last inspection meeting.

（Note:The English version of this report is for reference only）