II. Main findings

　　The 1108 deficiencies were identified and recorded in the observation inspection in 2016. It was identified in the classification analysis on the deficiencies based on Chinese GMP (2010 version) that: the deficiencies in six categories including Quality Control and Quality Assurance, Documentation Management, Equipment, Materials and Products, Verification and Qualification and Premises and Facilities accounted for 88% of all the deficiencies. Compared with those in 2015, the deficiencies in Documentation Management increased from the 4th place to the second place in terms of its ranking and still showed an increase of 7% (from 10.5% to 17.3%) under an atmosphere that enterprises are gradually strengthening the management of data integrity, fully reflecting the concern extent and strict requirements for data integrity in currently foreign inspections.

In pharmaceutical GMP inspections by foreign organizations, the deficiencies in “Quality Control and Quality Assurance” topped the list, accounting for 27.3%. Main problems focused on the management of computerized analysis instruments in the laboratory, deviation handling and CAPA, product quality review, change control, OOS/OOT result processing, the laboratory’s failing to meet the provisions for control procedure, microbial inspection management, quality risk management and stability test. The deficiencies in “Documentation Management” ranked the second, mainly focusing on four aspects including the completeness and traceability of records, life cycle management of documents, document completeness and record operation. The deficiencies in “Equipment” ranked the third, of which the deficiencies in the using and cleaning, calibration, maintenance and repair of equipment and water preparation system accounted for 83.6%. The deficiencies in “Materials and Products” focused on supplier management, identification of materials and products, process management of materials, compliance with material and product standards and release management. The deficiencies in “Verification and Qualification” mainly included the scientificity of validation, validation management and validation documents and records. The deficiencies in “Premises and Facilities” mainly included environmental control, management of storage area, the measures to prevent pollution and cross-pollution and life cycle management of premise and facilities.

　　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）