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GOST 31889-2012 Principles of Good Laboratory Practice (GLP) Requesting and carrying out inspections and study audits in another country《良好实验室操作规程原则 在异国中要求和执行检查及研究审计》.pdf

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1、 318892012 , (C)INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC) (GLP) 318892012II, - 1.092 . - 1.22009 . -, . , , , 1 : - , , ( ); 339 , ; 339 , 2 .3 , (- 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYKGMDRUTJ -4 OECD series on Principles of Good Laboratory Practice and Co

2、mpliance Monitoring No 12 Advisory document of the working group on good laboratory practice. Requesting and carrying out inspections and study audits in another country: 2002 ( . : 2002, 12 () GLP -). GLP. (en). , , - . (IDT). : . - .5 27 2012 . 2152- 318892012 - 1 2013 . 318892012 III , 2013 -, 6

3、- , - . () . - , 318892012IV1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4、. . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 318892012 V - -, , . , 1997 ., -. (GLP) - - , , () () - ( GLP 1989 . C (89) 87 (Final), Part (II, 2.iii) 1. , GLP , , -. - (Hans-Wilhelm Hem-beck), , 2, 3 1999 . , , , , , , , . , , - 12- 2000 . . 30- , - . - - GLP GLP , 1 2. 1 318892012 (GL

5、P) Principles of Good Laboratory Practice (GLP).Requesting and carrying out inspections and study audits in another country 201301011 1.1 - (GLP).- GLP 1989 . ( (89) 87/Fi-nal) 1 , -, , GLP, , , , , - GLP ( -), , . , . 1.2 GLP, GLP , - . , , , . - GLP , , . 1.3 GLP , 1 , , GLP 2. , / - , , . - , GLP

6、, ( - ), , , -, , . 1.4 , , , - . , - , - GLP. - , . 31889201221.5 , GLP, - GLP, GLP .1.6 GLP , - GLP, -, . , , - GLP / -, , , / ( ). - , . , GLP , . 2 , 2.1 / . .2.2 - GLP .2.3 / , , - / . () , -, () / . / . C, , - / . 2.4 / , - ( , ), . 2.5 , / , - () () . 2.6 , , , . , , . 2.7 , , , / . 318892012

7、 31 C (89) 87 (Final) : 1989Amended on C(95)8/Final) : 1995(C (89) 87 (Final) :1989, C(95)8/Final) : 1995)Decision-Recommendation of the Council on Compliance with Principles of Good Laboratory Practice (- - )2 ENV/MC/CHEM(98)17 Principles on Good Laboratory Practice. OECD series on Principles of Good Laboratory Practice and Compliance Monitoring. No 1 ( - . - . 1) 3188920124 502.3/504.03:615/615.9:006.354 13.020.30 : , GLP, , , , . . . . 16.09.2013. 15.10.2013. 60841/8. . . . 1,40. .-. . 0,55. 67 . . 1151. , 123995 , ., 4.www.gostinfo.ru infogostinfo.ru . . , 105062 , ., 6.

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