Current Situation And Countermeasure Analysis Of GLP Institution In China

Objective:Drug non-clinical research was the important link of new drug researching. Although Good Laboratory Practice (GLP) in China caught up with the level of world, Drug non-clinical research started later, developing was not balanced and level relatively low, which restricted the strategy of drug independent researching. Therefore, this study aimed to find problems about institutions construction and operation by analyzing GLP situation, so as to provide reference for GLP perfection.Method:1. Literature analysis and comparative study:this study conducted a comprehensive literature review on domestic and international GLP laws and regulations, and analyzed the specific characteristics of GLP laws and regulations among China, America, Japan and other international organizations to find out the gaps of management and supervision system between China and others, meantime to indentify the weakness.2. Questionnaire survey and expert consultation:this study used the questionnaire " GLP institution survey" signed by Center for Certification of Drug investigated the situation of GLP institution construction and operation, and used the questionnaire " GLP institution satisfaction survey" investigated the level of inspectors satisfaction for GLP institution.3. Date processing and statistical analysis methodologies:data of questionnaires were input to Excel to verification, describing and inferring the results of questionnaires.Result:1. This study investigated the situation of GLP institutions in China, there are56institutions,9(16.1%) in Beijing,9(16.1%) in Shanghai and other economically developed provinces. GLP safety evaluation project focused on the single and multiple toxicity test (rodents)(55,98.2%).4731tests were completed until2012, and868(28.3%) tests were completed in2012, the largest tests completed was genetic toxicity (813,17.2%). There are2963employees in GLP institutions, and proportion was more of smaller institutions.45GLP institutions issued390articles from the year of2003,80SCI articles published, and the IF reached215.804. The animals’management level and conscious of GLP institutions were improved,41institutions (91.11%) had animal welfare organizations. However, only5institutions received foreign laboratory accreditation, the degree of internationalization was low.2. Through the study of the United States, Japan and other developed countries and international organizations’GLP supervision system and related laws and regulations showed that test plan and summary report could be approved by the study director(SD), but those need be approved by FM. Otherwise, FDA and OECD GLP put forward the specific requirements of electronic data collection, but lack of related regulations in China. Third, FDA GLP stipulated the if the test study period was more than4weeks, the sample need keep for a period of time, but lack of related regulations in China. At last, FDA not only stipulated the time of saving test data, but also stipulated the date saving in the special circumstances. China GLP only stipulated the time of data saving.3. This study summarized some problems of GLP though analyzing the result of GLP institutions inspection data. Mainly problems of organizational structure and personnel were SD (55.2%), such as not strict enforcement of trial protocol, prevention of trial materials and samples, and management of trial records. Mainly problems of experimental facilities and management were experimental animal breeding management facilities (34.5%), such as not strict management of animal quarantine and treatment in isolation facilities. Mainly problems of instruments and experimental materials were instruments (62.1%), such as instruments that need metrological verification had no certification. Mainly problems of SOP were SOP formulation, such as SOP of the experimental animal quarantine and other SOPs were imperfection and the operation not ideal. Mainly problems of research work implement were experimental operation and record (75.9%), such as there were no record about the process of research deviating from the protocol. Mainly problems of data file were the integrity of other files (17.2%), such as personnel and other archives were imperfection.4. This study used the questionnaire "GLP institution satisfaction survey" investigated the level of inspectors satisfaction for GLP institution so as to know the level of drug non-clinical research. The results showed that inspectors felt basic satisfaction for GLP institutions, especially to the research work (68.63%). However, there were29.41%inspectors not satisfying for the information management,15.69%not for employee training and13.73%not for files management.Conclusion:1. This study found that distribution of GLP institutions in China was not balanced. The usage rate of laboratory information system and the recognition degree of laboratory were low. There were many problems in aspects of FM management and SOP formulation. Therefore, according to the problems, promoting the institution construction and system improvement. Not only beneficial to the level of GLP improvement, but also beneficial to guide the management work of GLP institutions.2. Although the general content of GLP regulations had no difference between China and other countries and organizations, specific still had some difference. CFDA GLP was lack of related regulations in test electronic data collection, and the preservation of sample, not beneficial to quality control of test samples.3. This study used the questionnaire "GLP institution satisfaction survey" investigated the level of inspectors satisfaction for GLP institution. The results showed that inspectors felt satisfy with the GLP institutions. However some inspectors recognized to the information management. Therefore, GLP institutions should strength the information construction in order to improve the level of GLP study earnestly.