In order to further enhance the publicity of drug inspection information and improve the transparency of inspection work, the State Drug Administration has conducted on-site inspection of drug registration and production, GMP tracking and inspection of drugs, flight inspection of drugs, on-site inspection of overseas production of imported drugs, drug circulation inspection, GMP observation and inspection of international drugs in 2017. The "Drug Inspection Report 2017" (Chinese and English editions) has been compiled and analyzed. It is now published named Drug inspection report 2017 (Chinese version)
Preface
In 2017, the former State Food and Drug Administration organized 751 on-site inspections of drug registration and production, on-site inspection of generic drug consistency evaluation, GMP tracking inspection, flight inspection, on-site inspection of overseas production of imported drugs, circulation inspection and international observation inspection.
List of various drug inspection tasks completed in 2017

Section 1 Inspection on drug registration and production site

According to regulations and requirements ofthe Drug Registration Management Measures (No.28 of the State Food and Drug Administration) and Regulations on on-site Inspection of Drug Registration, they organized the inspection on production site, drug registration for inspection work. At the same time they carried outthe evaluation of quality and efficacy consistency about generic drugs and inspectionon production site according to theAnnouncement concerning the Evaluation of Quality and Efficacy Consistency of Generic Drugs.

1.     Check the basic conditions

A total of 68 inspection tasks were performed in 2017, with a total of 47 inspection teams and 168 peopleto conduct on-site inspections on the quality of 52 standards. Completed 45 on-site inspection reportsof which 42 passed, accounting for 93.3%,3 did not pass which accounting for 6.7 percent.

2. Main problems discovered

Among the problems found in the field inspection in 2017, data reliability problems such as untruthfulness of declared data and data intractability are no longer prominent. This has something to do with the fact that most of the 2017 registered production site inspection tasks have passed the clinical trial data verification, and that enterprises generally pay more attention to the problem of data reliability in the research and development process. However, there are many problems about the compliance of GMP before the approval, which indicates that the construction of quality management system is relatively weak and insufficient attention is paid to the compliance of GMP. In 2017, it was found that the company had problems in the process of research and development, such as insufficient implementation of production quality management standards, insufficiency of deviation and over-standard investigation, and unscientific process verification. The details are as follows:

(1) Insufficient implementation of GMP specifications in the pilot test or technology transfer process

At present, most enterprises have realized that the technology transfer from research and development to production needs quality management, but there are still some deficiencies. Some enterprises have not incorporated this process into the GMP system of drugs. There are some phenomena, such as unclear responsibilities of personnel, insufficient understanding of the knowledge of variety process by the production department and incomplete compliance of GMP regulations by the R&D department in the process verification.

(2) Insufficient investigation of deviation and exceeding standard results

There is a lack of timely investigation into the results of deviation and exceeding standards, or the investigation is not thorough and comprehensive, and the root causes are not fully investigated. Especially, when found the abnormal data of the stability test data deviated from the trend, insufficient attention was paid to it and the investigation was not conducted in time. It became very difficult to find the cause later.

(3) Unscientific and inadequate process verification

Some enterprises do not have sufficient research on the product and process at the early stage, do not have sufficient understanding of the process, and do not design scientific drug process validation schemes. Process validation deviation cannot be recorded and analyzed in accordance with GMP requirements. Root causes cannot be found and corrective and preventive measures can be formulated. Some enterprises even regard the continuous production of three batches of qualified products as the criteria for judging the process verification.

3. On-site Inspection of Quality and Efficacy Consistency Evaluation of Generic Drugs