Discussion the ongoing verification indicators and evaluation approachs of analytical procedure
Ongoing procedure performance verification(OPPV)of an analytical procedure is the process of ensu-ring it continues to meet its intended use after completion of validation.On the basis of previous studies,this pa-per further discussed the indicators of ongoing procedure performance verification(including system suitability in-dicators and reported values,etc.)and the implementation of analysis tools(control charts),and demonstrated the specific operation steps of ongoing procedure performance verification with examples.It is hoped that this pa-per will provide new ideas for the accurate and standardized procedure verification in the pharmaceutical field,es-pecially in the enterprises and regulatory departments.
procedure verificationongoing procedure performance verificationanalytical procedure life-cyclecontrol chartanalytical control attributes
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