GOST 31886-2012 The application of the Principles of Good Laboratory Practice to short term studies《良好实验室操作规程原则的短期研究应用》.pdf

《GOST 31886-2012 The application of the Principles of Good Laboratory Practice to short term studies《良好实验室操作规程原则的短期研究应用》.pdf》由会员分享，可在线阅读，更多相关《GOST 31886-2012 The application of the Principles of Good Laboratory Practice to short term studies《良好实验室操作规程原则的短期研究应用》.pdf（16页珍藏版）》请在麦多课文档分享上搜索。

1、 (GLP) GLP , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)318862012, - 1.092 . 1.22009 . -, . , , 1 : - , , ( ); 339 , ; 339 , 2 3 c , ( 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYKZKGMDRUTJ -4 OECD series on Principles of GoodLaboratory Practice and Compliance Moni

2、toring No 7 Consensus document The application of theGLP principles to short term studies:1999 ( GLP. - :1999, 7 - () GLP ). GLP. (en). , , . (IDT). : . .5 27 2012 . 2156- 318862012 - 1 2013 .II 3188620126 , - . () . - , , 2013 -, III 3188620121 .12 .12.1 GLP 1IV 318862012 - () (GLP), 58 1992 . - ,

3、(Interlaken) , GLP - . (Ms. Francisca E. Liem), , GLP . - - - (Dr. Hans-Wilhelm Hembeck, GLP). - GLP, : ,-, , . - ( ) - - (- ); - (David Long)() - (Stephen Harston) (). , , GLP , - . . - GLP 1993 ., , .20- ; . 1997 . GLP GLP GLP . GLP 1999 ., - , 1999 . . , GLP GLP, , 1999 . GLP , - , , . GLP , , GL

4、P . GLP, -, . GLP . , , , , , . GLP -: , , . , . , -, () , () - -. - - .V 318862012 GLP - , - . , -, - , -. , , , , .VI 318862012 (GLP) GLP Principles of Good Laboratory Practice (GLP).Application of GLP principles to short term studies1 1.1 ( GLP). GLP - . GLP . GLP , - GLP, - .1.2 GLP -, 1 ( I.2.3

5、.2). , , -.1.3 - , -, () ( , ), (, - ) , - . - , - , , , -, , . / , , GLP.2 2.1 GLP2.1.1 (1, II.1.2)2.1.1.2 (1, II.1.2) , , .1 318862012 20130101 (1, II.1.2 g). , . - , .2.1.2 (1, II.2)2.1.2.1 (1, II.2.1) , (1, II.2.1.1).1 - GLP 2. - , - (, 9000) .2 , , , 2.2.1.2.2 2.1.2.2.1 ; , .2.1.2.2.2 , (, , , , , -, . .).2.1.2.2.3 , , , - . , - , . , , , , - .2.1.2.3