遗传毒性试验的质量保证与现场检查.pdf

Ch inese Journal of New Drugs 20 10, 19 ( 11) ! ! , , , , ( 军事医学科学院毒物药物研究所国家北京药物安全评价研究中心, 北京 100850) [] 遗传毒性试验在毒理学试验中属于 期小型试验, 但因其测试终点的多样性及统计分析的 复杂性, 在药品非临床研究质量管理规范( GLP ) 和质量保证( QA ) 方面有其特殊性文中从实验室资质的确 认研究过程的核查原始资料和报告的审核现场检查等 4 个方面介绍遗传毒性试验质量保证的程序要求 和注意事项 [] 遗传毒性; 质量保证; 药品非临床研究质量管理规范 [] R 99; R 95 [] C [ ] 100 3- 37 34( 2010) 11- 0937 - 03 Quality assurance and field in spection of gen etic toxicity tests GUO Q iaozhen, W U Chunq ,i MA H u azh ,i L IAO M ingyang, D ING R igao (Institute of Toxicology and Pharmacology, Academy of M ilitary M edicalSciences, N ationalBeij ing Centerf or Drug Saf ety valuation and Research, Beijing 100850, China) [ Abstract] Am ong the tox ico log ical tests o f m ed icina l chem ica ls, the genetic tox ic ity tests consist of about 100 sho rtterm and sm a ll scale tests. Becau se of the diversity of the test endpo ints and the comp lex ity o f the ir sta tistica l ana lysis, they h ave brought m uch cha llenge to qu a lity assurance ( QA ) and assessm ent for the ir regu latory com pliance. In this art icle, the procedure, requ irem ents, and som e sp ec ia l concerns for the QA o f the geno tox icity tests w ere briefly out lined. T he qu alification s of the genetic tox ico logy labs, the inspection of the study process, the aud it of the raw data and study reports, and the field in sp ection of the testing fac ility by regu latory authority w ere p art icularly em phasized. [K ey w ords] genet ic tox icity; qu ality assurance; good labo ratory pract ice ( GLP ) ( Q C ) , , QA ,