II. Main findings

　　(I) Overall situation

A total of 2271 deficiencies were identified in 204 inspections, of which there were 22 critical deficiencies, 210 major deficiencies and 2039 general deficiencies. Compared with GMP certification and follow-up inspections in 2015, the number of critical deficiencies was increased.

Among the manufacturers of high-risk varieties subject to special inspection, out of production for a long time or failing in pharmaceutical GMP (2010 version) certification were prominent. The common problems identified in the inspections were as follows:

1. Individual enterprise had inconsistency between its production process and registered process.

2. The problems in data integrity and authenticity still existed, including falsification of production records, indiscriminate use of maps and arbitrary modification of data in inspection records and inconsistency in relevant content in production, equipment and material records.

3. The process validation was insufficient, and the enterprises failing to conduct process validation after changing production lot size had more problems.

4. The problems in the standardization of data management were prominent, mainly manifesting as failing to control the permission setting of the system, audit tracking function and the permission for the modification and deletion of documents and data, and having no reasonable control and explanation for deleting, selecting and using data.

5. There was certain gap between the implementation of the Appendix of Computer System and Appendix of Qualification and Validation and regulatory requirements, and many problems were identified.

6. There was a weak management of deviations and changes, mainly manifesting as failing to effectively identify and record the deviations that occurred, and lacking necessary assessment and validation for the changes.

　(II) The enterprises unqualified in casual inspections in 2015

A total of 11 critical deficiencies, 27 major deficiencies and 84 general deficiencies were identified in the inspections on 11 enterprises.

　　Main findings were as follows:

1. Production process was inconsistent with registered process

2. Problems in data integrity

3. Problems in process validation

(III) Double random inspection

A total of 5 critical deficiencies, 24 major deficiencies and 123 general deficiencies were identified.

　　Main findings were as follows:

1. Record falsification

2. Potential hazards in product quality and safety

3. Problems in data integrity

4. Problems in process validation

5. Non-standardized material management with the risks in pollution, confusion and error.

6. Incomplete cleaning, which cannot effectively prevent contamination and cross-contamination.

(IV) Vaccine manufacturers

38 major deficiencies and 383 general deficiencies were identified.

　　Main findings:

1. Equipment. There was a too long stagnant water section between the stainless steel pipe valve through which water for injection preparation system enters into injection water storage tank and water generator; Individual device had rust.

2. Materials and Products. The quantity of the destructed items was not recorded in the destruction records of the non-conforming finished products; the enterprise failed to establish the background information of whole-genome sequence of main bacterial and viral seeds for production.

3. Documentation Management. Individual document was not specifically specified and was poor in its operability. The content specified in the document was inconsistent with the actual situation; individual record had incomplete content; the batch production records were unreasonably designed and were not timely filled in actual operation.

4. Quality Control and Quality Assurance

(1) Quality management of laboratories: the enterprise failed to request necessary test data and maps from the institutions conducting entrusted test; some material was subject to infrared test after sample mixing.

(2) the Deviation handling: The training and implementation of the documents related to deviation handling was not conducted; the enterprise failed to timely initiate the investigation for individual deviation; the reason analysis and corrective and preventive measures for a few deviations were not in place, and there was in adequate assessment on the potential impact of the deviations on the quality of products.

(3) Change control: The enterprise failed to handle the changes in accordance with change process and submit supplementary application for registration. There was no or inadequate assessment on some changes;

(4) Supplier management: There was incomplete auditing content for the suppliers of some materials, and the enterprise failed to determine the auditing content for suppliers based on the impact of the material on product quality.

(5) Product quality review: The enterprise failed to conduct annual quality review by varieties.

5. Computer System. The enterprise has developed document system for computer system management, but did not conduct classification management in accordance with the system, and did not take effective measures to reduce risks for the situation that existing conditions failed to comply with the document; there was no permission setting for the login screen of HPLC testing equipment in quality verification laboratory, and no measures to prevent the login by the unauthorized person.

(V) Blood product manufacturers

In the inspections on 25 enterprises, 13 major deficiencies and 241 general deficiencies were identified, and no critical deficiency was identified.