GOST 31884-2012 Principles of Good Laboratory Practice Compliance of laboratory suppliers with GLP Principles《良好实验室操作规程原则 遵从GLP原则的实验室供应商依从性》.pdf

1、 (GLP) GLP , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)318842012, - 1.092 . 1.22009 . -, . , , 1 : - , , ( ); 339 , ; 339 , 2 3 c , ( 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYKGMDRUTJUZ -4 OECD series on rinciples of GoodLaboratory Practice and Compliance Monit

2、oring 5 Consensus document Compliance of laboratorysuppliers with GLP Principles:1999 ( . GLP:1999, 5 - () GLP ). GLP. (en). , , . (IDT). : . 5 27 2012 . 2162- 318842012 - 1 2013 .6 II 318842012 , - . () . - , , 2013 -, III 3188420121 .12 GLP 22.1 22.2 -.22.3 , .22.4 .22.5 , 22.6 () 32.7 32.8 32.9 .

3、32.10 .42.11 , .4 5IV 318842012 , - 1618 1990 . -, (Bad-Dc104rkheim, Germany), -(Dr.DavidMoore), - GLP , - GLP. GLP , -, , , , . , GLP, GLP. , . . , , . GLP, - . . 1997 . GLP GLP -, GLP . 1999 ., , 1999 . . ,GLP , , - . , -,- . , , p , - GLP, , - . , GLP, - . , , GLP,- .V 318842012 (GLP) GLPPrincipl

4、es of Good Laboratory Practice (GLP).Compliance of laboratory suppliers with GLP principles1 , - GLP; GLP, , - GLP. 1( II.1). , - GLP, , , - . , . , , - GLP, GLP, , - . , GLP 1, . , , - GLP, - GLP. , - , , GLP / , . , , , . , , .1 318842012 201301012 GLP2.1 ,- GLP.2.1.1 , - , GLP. , - . , - , , GLP.

5、2.1.2 9001:2008, -, 1. , , , 2. - / 17025:2005 3, .2.1.3 . () - , , - . , - , / .2.1.4 GLP, GLP -, C(81)30(Final) GLP C(89)87(Final) 1.2.2 - GLP 1 ( 5b) II.8.2) , - (, ) . , . , GLP , (, ), - , - .2.3 , GLP , , -. , , - . , . - .2.4 GLP - GLP. () , (-) , GLP. - GLP.2.5 , 2.5.1 , , , . -2 318842012 , ,