GOST 31880-2012 Principles of Good Laboratory Practice Guidance for the conduct of laboratory inspections and study audits《良好实验室操作规程原则 实验室检查和研究审计实施导则》.pdf

1、 (GLP) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)318802012, - 1.092 . 1.22009 . -, . , , 1 : - , , ( ); 339 , ; 339 , 2 3 c , ( 15 2012 . 42) : ( 3166) 00497 ( 3166) 00497 AMBYKZKGMDRUTJ -4 OECD series on Principles of GoodLaboratory Practice and Compliance Monitori

2、ng No 3 Revised guidance for the conduct of laboratoryinspections and study audits:1995 ( -:1995, 3 () GLP ). GLP. (en). , , . (IDT). : . 5 27 2012 . 2161- 318802012 1 2013 .II 3188020126 , - . () . - , , 2013 -, III 3188020121 .12 13 23.1 .23.2 23.3 33.4 .33.5 43.6 , - 43.7 , , 53.8 -.53.9 .63.10 .

3、63.11 .63.12 73.13 .74 .75 8 () - 10 .12IV 3188020121981.C(81)30(Final),-OECDSeriesonprinciplesofgoodlaboratorypracticeandcompliancemonitoring No1 OECDPrinciplesofGoodLaboratoryPractice(GLP)-.1.-GLP1( GLP), , GLP. , , 1983 . C (83) 95 (Final), . GLP ( )1985.(.Silano), GLP, ,GLP,- . :, , , , , , , ,

4、, , , , , ,(). , , - . , GLP,1982. 1988 .; - GLP 1989 .C (89)87(Final),1983. - - GLP- ,-.GLP, : -,-91995.C(95)8(Final).V 318802012 (GLP) Principles of Good Laboratory Practice (GLP).Guidance for the conduct of laboratory inspections and study audits1 . , - GLP c92 . , , , , , -. 4,5. - GLP, , -, . ,

5、 GLP. - , , - GLP. - GLP (, ).2 2.1 GLP , , . , - , , . .2.2 ( , ), , , - GLP. , - GLP .1 318802012 20130101 3 , - , , , . , , . .2.3 - . , -.2.4 . , - , , - .2.5 , . , - . () - GLP.3 3.1 , -, , -. , .-.- , , , , . :- , ;- , ;- . , , , - . , , . , . , ., , .3.2 - , , , , , . . :- ;- , , , , , - , . . , , - ;2 318802012- ()-;- , GLP,-GLP;- (),;- (),-