Saturday , 21 December 2024

A NOVEL REVIEW ON ANALYTICAL VALIDATION

E. Anka Rao

About author :
E. Anka Rao*, SK. JuveeriaD. Kiran Kumar
K.V.S Prasad, S.Suneetha, M.Madan Mohan Reddy
Narayana Pharmacy College, Nellore,  AP, India
*E-mail : ankarao25@yahoo.co.in

ABSTRACT:
validation is the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It is divided into a number of subsections including the following: Process validation, Analytical method validation, Computer system validation.  An  analytical  method  details  the  steps  necessary  to  perform  an  analysis. This  may include:  preparation  of  samples, standards  and  reagents;  use  of  the  apparatus; generation of the calibration curve, use of the formulae for the calculation, etc. The use of analytical methods during drug development and manufacturing provides information
Key Words : Analytical method validation, regulatory agencies, validation characteristics, Method validation

 

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