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3 1999 . N 432/512 " 42-510-98 " (GMP)" ( 29 2001 .) " "*,* 24 1998 . N 650 " " 1998-2000 2005 "**** , , : 1. , ( - -), : , 1 2000 ., 42-510-98 " (GMP)", 25 1998 .; 42-510-98 " (GMP)", 31 2005 . ( , , 31 2008 .) 1 2000 . . 2. ( ..) , ( ..): 1 2000 . 42-510-98 " (GMP)", , , ()- . 42-510-98 " (GMP)" -. 3. , 1 2000 . -, , 42-510-98. 4. .. . . . . 42-510-98 " (GMP) (. 25 1998 .) ( 3 1999 . N 432/512) ( 29 2001 .) 64-125-91 . , . N 1, 29 2001 ., , , , , , . , " . " N 91500.05.001-00. (B03) ("World Health Organization" - WHO " " ( ), 1992 . : - ; - ; - GMP ("Good manufacturing practice" - " "). 140 . , - , GMP. , , GMP. GMP , . GMP , . GMP 1963 ( 1965, 1971, 1978, 1987, 1989, 1992 .), - , , , . ( GMP) 40 . , GMP, : GMP ("European Community" - ), GMP - " " ("Convention for the Mutual Recognition of Inspection on Respect of the Manufacture of Pharmaceutical Products" - PIC), GMP ASEAN ("Association of South East Asian Nations" - ASEAN) - - - GMP - GMP . GMP (" " 64-125-91) 1991 . , . GMP ("International Organization for Standardization - ISO), 9000-9004, , , . , , GMP. GMP 64-125-91 ( ). . , . , , , . . : , , , , , , , , , . , " ", " ", " " "" . , "" GMP . . . , . . 1. : - - , " ". - , , , , , , , , , , , , . , , . - , . - . N 1, 29 2001 ., 1 : - , - , ( ), , . : - , 22.06.1998 N 86- " " ( )*(1) . , - .*(2) - - - , - , () ( ).*(3) - , , . - - , - , - ( ).*(4) 2. (Quality Management) стр.1Перейти на стр.2Перейти на стр.3Перейти на стр.4Перейти на стр.5Перейти на стр.6Перейти на стр.7Перейти на стр.8Перейти на стр.9 |