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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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1、 153782014 9001:2008 (GMP)ISO 15378:2011Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with referenceto Good Manufacturing Practice (GMP)(IDT) 1 - ( ) ,42 0763 12014.839-4 15378:2011.9001:2008- (GMP) (ISO 15378:2011 Primary packagingm

2、aterialsformedicinalproducts ParticularrequirementsfortheapplicationofISO9001:2008,withreferencetoGoodManufacturingPractice(GMP).- -,5 1.02012 ( 8). ( 1 ), -.()- .,- (gost.ru),2015 , -II 1537820141 .11.1 11.2 .12 23 24 .84.1 .84.2 .95 115.1 .115.2 115.3 115.4 .125.5 , 125.6 136 .136.1 .136.2 136.3 1

3、46.4 146.5 .157 167.1 .167.2 , .167.3 .177.4 197.5 .207.6 .248 , .258.1 .258.2 .258.3 278.4 .278.5 .27 () GMP . 29 () .32 () - 38 () .4345III 1537820140.1 GMP - , . GMP - , - . GMP - - . - 9001:2008. :- , 9001:2008, - ;- , , GMP, . GMP 3. . -. :) , , ;b) ;c) ;d) ;e) ;f) . . , , . , -, -. , - , , , (

4、 ), . , - 9000 9004. 9001:2008 - . - , GMP . . .0.2 , - - . . , , . .IV 153782014 , , , - . , - , -. :) ;b) ;c) -;d) , . 1 , , , 48. , , - . - . 1 , . , Plan Do Check Act (PDCA). PDCA :- (plan) , - ;- (do) ;- (check) , ;- (act) . 9001:2008V 153782014 1 , 0.3 9004 9001 9004 , - , . 9001 , , - . . 900

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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