Abstract
REVIEW REPORT ON REGULATORY AGENCIES REQUIRMENT AND EXPERIMENTAL APPROCH FOR METHOD VALIDATION AND METHOD VERIFICATION

U. R. Maniyar*, Kishor Koshe, Dr. M. V. Katariya, Dr. G. S. Karva, S. H. Jaiswal, Dr. V. R. Katariya

ABSTRACT

The objective of presented review article is to provide the detailed theoretical approach regarding the method development and validation as per various regulatory agencies guidelines required for the drug material and product thereof. The present review also deals with the most appropriate experimental approach for analytical method validation and method verification which is required for the routine analysis of pharmaceutical products for qualitative and quantitative estimation. In brief the objective of this review is to estimate the uncertainty of measurement of developed method using statistical application.

Keywords: ICH Guidelines, method development and validation, regulatory agencies.


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