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GOST 31888-2012 Principles of good laboratory practice The role and responsibilities of the sponsor in the application of GLP principles《良好实验室操作规程原则 GLP基本原则应用中赞助者的角色和职责》.pdf

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1、 (GLP) GLP , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)318882012, - 1.092 . - 1.22009 . , . -, , , 1 : - , , ( ); 339 , ; 339 , 2 3 , (- 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYKZKGMDRUTJ -4 OECD series on Principles of GoodLaboratory Practice and Compliance M

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5、- , , : , - .3.1.4 GLP 1:3.1.4.1 : - , , 1 ( 6.2.3). GLP , - .3.1.4.2 : 1 ( 8.1.1), - , . - -.3.1.4.3 : , , 1 ( ) 8.2.2). . - , - , , 1 ( ) 8.2.3).3.1.4.4 : , , 1 (- ) 9.2.2).3.1.4.5 : , , -, () () 1( 10.4) , , , , , , - GLP.2 3188820124 4.1 , , .4.2 GLP 1 , (, 6.2.1, 6.2.2; d) 9.2.1). -. , -, . , . , - GLP . , , .4.3 , , ,- , , / .3 3188820121 OECDseries onrinciples of GoodLaboratoryPract

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