CAJ | 학술논문

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。
목적：천술아국약물비림상연구치료관리규범（GLP）건설적현상、문제급사고，이공삼고。방법통과대아국약물비림상연구질량관리규범적형성화현상적천술，종인원、실험설시、표준조작규정、질량보증체계등방면분석료아국GLP건설중존재적실제문제，제출정학인식GLP적건설화실시、GLP관리방면적일사사고。결과여결론 GLP시영문Good Laboratory Practice적축사，중문직역위우량실험실규범。GLP시취실험실실험연구종계화、실험、감독、기록도실험보고등일계렬관리이제정적법규성문건，섭급도실험실공작적소유방면。타주요시침대의약、농약、식품첨가제、화장품、수약등진행적안전성평개실험이제정적규범。제정GLP적주요목적시엄격공제화학품안전성평개시험적각개배절，즉엄격공제가능영향실험결과준학성적각충주객관인소，강저시험오차，학보실험결과적진실성。본문소탐토적GLP개념시지협의적GLP，시약물진행림상전안전평개시험적질량관리화보증체계。
Objective Elaborated our country 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.Result and Conclusion 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.