GOST 31890-2012 Principles of Good Laboratory Practice The application of the OECD Principles of GLP to the organisation and management of multi-site studies《良好实验室操作规程原则 GLP多点研究组织管.pdf

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1、 (GLP) , , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)318902012, - 1.092 . - 1.22009 . , . , , -, 1 : - , , ( ); 339 , ; 339 , 2 3 , (- 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYKGMDRUTJ -4 OECD series on rinciples of GoodLaboratory Practice and Compliance Monito

2、ring No 13 Consensus Document of the Working Group onGood Laboratory Practice The Application of the OECD Principles of GLP to the Organisation andManagement of Multi-Site Studies:2002 ( - . GLP , :2002, 13 () GLP ). GLP. (en). , , . (IDT). : . .II 3189020125 27 2012 . 2157- 318902012 - 1 2013 .6 ,

3、 . () . - , , 2013 -, III 3189020121 12 . . . 12.1 .12.2 22.3 .22.4 22.5 32.6 52.7 - 52.8 62.9 62.10 .72.11 72.12 8 .9IV 318902012 . , , ; , . , , . (GLP), 2123 1991 . . , , GLP . - GLP 1992 . 1999 . ENV/JM /MONO (99) 23 1. , , . , , - , . 1997 . GLP 2 - . . -, , - , ,., - -, , , - , ; , . , , , ,

4、 -, . - (Horley), , 2001 . 2001 . GLP 2002 . -, . . .V 318902012 (GLP) , Principles of Good Laboratory Practice (GLP). rganisation and management of multi-site studies 201301011 , . , , , -, , - . .2 2.1 2.1.1 , , , , - , , -, GLP.2.1.2 , -, , , -. , , , , GLP. , - . , , , - , . , , , - , .2.1.3 , , - , . - , , , (), .1 318902012 2.1.4 - - , - GLP. GLP , .2.2 2.2.1 , , , . , -, . , .2.2.2 , .2.2.3 , - . - , . , - , , . / , GLP, - .2.3 2.3.1 , . , - , - , , , (), .2.3.2 , , - . .2.4 2.4.1 . , , c92 . - , , ( ).2.4.2 - - ,- () () () () -(). , , - ,-,- . - .2.4.3 - .

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