GOST 33044-2014 Principles of good laboratory practice《良好生产实践原则》.pdf

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1、 (OECD Guide 1:1998, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)330442014, 1.092 . 1.22009 . , - . , , , 1 - , , - ( ) , 52 (-)3 , (- 20 2014 . 71-) : ( 3166) 00497 ( 3166) 00497 AMBYKGMDRUUA - 4 20 2014 . 1700- 330442014 - 1 2015 .5 OECD Guide 1:1998 OECD Princ

2、iples ofgood laboratory practice ( ). (en). (IDT)6 - , - . () - . , , 2015 -, II 330442014112.13 .3 () .11III 330442014 - , , () (GLP). , - , - . , - , - . 19791980 . , , , - . (GLP) (OECD. Principles of Good Laboratory Practice(GLP). GLP 1981 . C(81)30(Final). 19951996 . , - (GLP). , , . - (GLP), -

3、 1981 . (GLP) , , . - , , . - , , . (GLP) - . (), - OECD, Guide 1:1998 OECD. Principles of good laboratory practice. - .IV 330442014 Principles of good laboratory practice 201508011 , - -, , , , , , . , , , , . , / / . , , , . - , - , , , , , , , .2 :2.1 2.1.1 (Good Laboratory Practice (GLP): , , ,

4、, - , .2.2 2.2.1 (test facility): - , , -, . , , - , , - .2.2.2 (test site): - .1 330442014 2.2.3 (test facility management): , - .2.2.4 (test site management): ( ), () () () - .2.2.5 (sponsor): , , , / - .2.2.6 (study director): , - .2.2.7 (principal investigator): , - - . () , - , , .2.2.8 (qualit

5、y assurance programme): , - , , - .2.2.9 ; (standard operating procedures; SOPs): - , -, , .2.2.10 - (master schedule): , - .2.3 2.3.1 (non-clinicalhealth and environmental safety study): , - , / .2.3.2 (short-term study): , .2.3.3 (study plan): , , , .2.3.4 (study plan amendment): , .2.3.5 (study p

6、lan deviation): .2.3.6 - (test system): , - , .2.3.7 (raw data): - , , - . : , , -, , -, , -, , - (. 2.3.10).2.3.8 (specimen): , - , .2.3.9 (experimental starting date): - .2 3304420142.3.10 (experimental completion date): .2.3.11 (study initiation date): - .2.3.12 (study completion date): .2.4 2.4.1 (test item): , .2.4.2 (), () (reference item,control item): (), , - .2.4.3 , (batch, lot): -, , .2.4.4 (vehicle): , , - -.3 3.1 3.1.1 3.1.1.1 , .3.1.1.2 , :) , (), - ;b) , -, , -;c) ,

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