GOST R ISO 15378-2014 Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001 2008 with reference to Good Manufacturing Practice .pdf

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5、1:2008 9004 -. 9004 , -. 9004 , 9001; - . , -. 9001:20080.4 14001:2004 . A 9001:2008 14001:2004. , , -, . - . () () , - . 9001:2008 9001:2008 - , GMP -, , .VI 153782014 9001:2008 (GMP)Primary packaging materials for medicinal products.Particular requirements for the application of ISO 9001:2008, with reference to good manufacturing practice (GMP) 201506011 1.1 , - , -, , . . - , , . , :) , ;b) - , , - .1 :) ;b) .2 . 9001:2008 , . .1.2 , . - () , . , 7 1 153782014 , - . 9001:20082 . . - ( ). .

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