About author :
E. Anka Rao*, SK. Juveeria, D. 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