GOST 31879-2012 Principles of Good Laboratory Practice (GLP) Guides for compliance monitoring procedures for GLP Principles《良好实验室操作规程原则 良好实验室操作规程一致性监管程序指南》.pdf

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GOST 31879-2012 Principles of Good Laboratory Practice (GLP) Guides for compliance monitoring procedures for GLP Principles《良好实验室操作规程原则 良好实验室操作规程一致性监管程序指南》.pdf_第1页
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GOST 31879-2012 Principles of Good Laboratory Practice (GLP) Guides for compliance monitoring procedures for GLP Principles《良好实验室操作规程原则 良好实验室操作规程一致性监管程序指南》.pdf_第3页
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GOST 31879-2012 Principles of Good Laboratory Practice (GLP) Guides for compliance monitoring procedures for GLP Principles《良好实验室操作规程原则 良好实验室操作规程一致性监管程序指南》.pdf_第4页
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GOST 31879-2012 Principles of Good Laboratory Practice (GLP) Guides for compliance monitoring procedures for GLP Principles《良好实验室操作规程原则 良好实验室操作规程一致性监管程序指南》.pdf_第5页
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1、 (GLP) GLP , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)318792012, - 1.092 . - 1.22009 . , . -, , , 1 : - , , (); 339 , ; 339 , 2 3 , (- 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYKGMDRUTJ -4 OECD series on Principles of GoodLaboratory Practice and ompliance Monit

2、oring No 2 Revised guides for compliance monitoringprocedures for good laboratory practice:1995 ( :1995, 2 - () GLP ). GLP. (en). , , . (IDT). : . 5 27 2012 . 2149- 318792012 - 1 2013 .II 3187920126 , - . () . - , , 2013 -, III 3187920121 .12 13 23.1 .23.2 .23.3 .23.4 GLP 33.5 43.6 .5 () - C(89)87(F

3、inal) .6 () - .8 () - - 1012IV 3187920121981.C(81)30(Final),- OECD Series on Principles of Good Laboratory Practice andCompliance monitoring No 1 OECD Principles of Good Laboratory Practice (GLP) ( . 1. GLP) 1( GLP) -, GLP. , - GLP, , 1983 . -C(83)95(Final),GLP. GLP ( )1985. ., (.Silano),- GLP, ,GLP

4、GLP.:, , , , , , , - , , ,(). , , -, GLP. -GLP1989.C(89)87(Final). - - GLP- ,-.GLP- - . : -,91995.C(95)8(Final).V 318792012 (GLP) GLPPrinciplesofGoodLaboratoryPractice(GLP).GuidesforcompliancemonitoringproceduresforGLPPrinciples1 ,-,. () , GLP , , ,-,GLP. , GLP GLP,- , , . GLP,-,-GLP.2 :2.1 GLP (G

5、LP principles): , 1.2.2 GLP (GLP Compliance Monitoring): /-GLP.2.3 () GLP (national) GLP complianceprogramme):,- , .2.4 () GLP(national)GLPmonitoringauthority):,- , 1 318792012 20130101 , . , .2.5 (test facility inspection): GLP. - , , , - , .2.6 (study audit): , , - , - , , , , -, .2.7 (inspector):

6、 , () GLP.2.8 GLP (GLP compliance status): GLP () GLP.2.9 (regulatory authority): , .3 3.1 3.1.1 GLP - , , .3.1.2 , , :- , () GLP , / , ;- , GLP ;- , () GLP, , - , , (, -, ), , , / . .;- ( GLP), .3.2 3.2.1 , () GLP - , - .3.2.2 , , :- , - , GLP;- , , , , / .3.3 3.3.1 GLP , .2 318792012 :i) , () - GLP;ii) GLP;iii) , ;iv) , .3.3.2

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