我国药物非临床研究质量管理规范(GLP)建设的现状、问题及思考

The Current Situation,Problems and The Thoughts Concerning the Construction of the GLP Quality Systems in China

目的阐述我国药物非临床研究治疗管理规范(GLP)建设的现状、问题及思考,以供参考。方法通过对我国药物非临床研究质量管理规范的形成和现状的阐述,从人员、实验设施、标准操作规程、质量保证体系等方面分析了我国GLP建设中存在的实际问题,提出正确认识GLP的建设和实施、GLP管理方面的一些思考。结果与结论 GLP是英文Good Laboratory Practice的缩写,中文直译为优良实验室规范。GLP是就实验室实验研究从计划、实验、监督、记录到实验报告等一系列管理而制定的法规性文件,涉及到实验室工作的所有方面。它主要是针对医药、农药、食品添加剂、化妆品、兽药等进行的安全性评价实验而制定的规范。制定GLP的主要目的是严格控制化学品安全性评价试验的各个环节,即严格控制可能影响实验结果准确性的各种主客观因素,降低试验误差,确保实验结果的真实性。本文所探讨的GLP概念是指狭义的GLP,是药物进行临床前安全评价试验的质量管理和保证体系。

Objective Elaborated ourcountry pharmaceutical non clinical study on the treatment of management specification （GLP） status,problems and Thinking on the construction,for reference.Methods This article illustrates the actual status of GLP in China and analyzes practical problems including staff, laboratory facilities,standard operating procedures and quality assurance system. Furthermore,this article gives suggestions on enhancing building,implementation and management of GLP.Resu I t and Conc I us i on GLP is the English Good Laboratory Practice abbreviation,Chinese translation for good laboratory practice.GLP is the regulatory documents on the laboratory experiment from the plan,experimental,supervision,recorded in the test report and a series of management and development,all aspects related to laboratory work.It is mainly the safety evaluation experiment for medicine,pesticide,food additive,cosmetic,medicine of standard established.The main objective for GLP is to strictly control the safety evaluation of chemicals each link testing,strict control may influence the results of various subjective and accuracy factors,reduce the experimental error,ensure the authenticity of experimental results.This paper discusses the concept of GLP refers to the special GLP,drug quality management test pre clinical safety evaluation and guarantee system.