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5、signQualification);- (IQ InstallationQualification);- (OQ OperationQualification);- (PQ PerformanceQualification).2 (validationmasterplan)-. .4 4.1 :- ( ), . . ,;-;-. , -,:-,.;-,-. , .2 525372006 , , , -.4.2 :) -. , , , - .b) , . -, , .) - .d) - .e) , .,- . .g) 52249 , , , -.h) , -.i) -, , , -, . .j) , -; , ; - ; , . . , , , , - , .k) :- (, , , .);- , .;- ( , - ).4.3 .4.3.1 , - 4.4.4.3.2 , - , , , . ( ) - 5.4.3.3 ,
