The Current Situation, Problems And Their Countermeasures For The Construction Of The GLP Quality Systems In China

The Good Laboratory Practices for non-clinical laboratory studies (the GLP regulations) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. It is the last barrier for the safe clinical trial of Investigative New Drug upon first dosing in human. As an administrative regulation and a quality system, the GLP is composed with the 5 essential elements of the Personnel, Procedures, Processes, Resources and the Monitoring, and with such sections as Test Facility Organization and Personnel, Quality Assurance (QA) Unit, Facilities, Apparatus, Material, and Reagents, Test Systems, Test and Reference Articles, Standard Operating Procedures(SOPs), Performance of the Study, Study Reports, and the Storage and Retention of Records and Materials, formulated on their historical and objective necessity. China formally promulgated its GLP regulations at 2003, and has made some achievement on the compliance with the GLP standard for its non-clinical laboratories. But there is a long way to go for achieving a fully enforcement and compliance, and the Mutual Acceptance of safety Data on non-clinical studies. In this study, the current problems and defects in the Chinese GLP facilities are surveyed by on site inspection, and the key and error-prone procedures in the performance of GLP studies are expert inquired by a questionnaire method. Based on the survey results, some proposals or countermeasures to the problems and defects found in the survey are suggested. It is our opinion that for the steady development of Chinese GLP system, the administrative authority should adjust its monitoring policy, improve the current GLP regulation, and enhance the executive authority. The GLP facilities should change its management systems, strengthen its domestic or foreign exchange and cooperation. Except for the improving the QA program, the quality control of the staff should introduced either. The quality management for Facilities, Apparatus, Material and Reagents, Test Systems, Test and Reference Articles, SOPs, the Computerized Systems, and the Storage and Retention of Records and Materials should all been improved, updated and adapted to the development of international GLP practice. Furthermore, a specialized QA system, based on the special requirements and the characteristics of different GLP tests (long-term toxicity tests, reproductive toxicity tests, toxic pathological examinations, genetic toxicity tests, analytical laboratory tests, safety pharmacology tests) should been established and implemented.