GOST 31900-2012 Principles of Good Laboratory Practice (GLP) Guidance for the preparation of GLP inspection reports《良好实验室操作规程原则 GLP检验报告制定导则 n》.pdf

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GOST 31900-2012 Principles of Good Laboratory Practice (GLP) Guidance for the preparation of GLP inspection reports《良好实验室操作规程原则 GLP检验报告制定导则 n》.pdf_第1页

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1、 319002012 , (C)INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC) (GLP) 319002012II, - 1.092 . - 1.22009 . -, . , , , 1 : - , , ( ); 339 , ; 339 , 2 3 , (- 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYMDRUTJ -4 OECD series on Principles of Good Laboratory Practice and Compl

2、iance Monitoring No 9 Consensus document Guidance for the prepa-ration of GLP inspection reports:1995 ( GLP. - : 1995, 9 () - GLP ). GLP. (en). , , . (IDT). : . - 5 27 2012 . 2160- 319002012 1 2013 . 319002012 III , 2013 -, 6 - , - . () . - , 319002012IV1 . . . . . . . . . . . . . . . . . . . . . .

3、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 GLP . . . . . . . . . . . . . . .12.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12.2 . . . . . . . . . . . . . . . . . . .

4、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5、 . . . . . . . . . . . . . . . . . . . . . . . .4 319002012 V () - (GLP) 2123 1994 . (Rockville), , , , GLP. - (Mr.Paul Lepore) - . GLP : , , , , , . - , GLP , - , GLP. GLP , , , -, , . - .1 201301011 GLP , .2 GLP GLP - GLP, . - GLP GLP. , . GLP, GLP , / , , , GLP, . - GLP. 2.1 , , . , , , , , . , -

6、 , GLP, , . .2.1.1 , , GLP . GLP, . 319002012 (GLP) Principles of Good Laboratory Practice (GLP).Guidance for the preparation of GLP inspection reports 31900201222.1.2 :2.1.2.1 , , .2.1.2.2 .2.1.2.3 ( , - . .).2.1.2.4 , , () ( () ).2.1.2.5 , - , .2.1.2.6 GLP, GLP , - .2.1.3 -, . , GLP, :2.1.3.1 ;2.1

7、3.2 ;2.1.3.3 ;2.1.3.4 , , ;2.1.3.5 -;2.1.3.6 () ;2.1.3.7 ;2.1.3.8 ;2.1.3.9 ;2.1.3.10 . GLP ( , -, - . .). . , , , - . , , .2.1.4 / - -, GLP, - / . , , GLP. . ; ( , .). GLP, / . - . - - . - , , - , , - . - . 319002012 32.1.5 , . :- ;- ;- , - ;- ;- .2.2 , , - GLP . , - , , , - . , , . , , , . , - GLP . . 2.3 - . 31900201241 ENV/MC/CHEM(98)17 Principles on Good Laboratory Practice. OECD series on Principles of Good Labora-tory Practice and Compliance Monitoring. No 1 ( . - . 1) 319002012 5 502.3/504.03:615/615.9:006.34 13.020.30 : , GLP, , , , , . . . . 17.09.2013. 14.10.201

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