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Abstract

A REVIEW: INTRODUCTION AND OVER VIEW STUDY ON PHARMACEUTUICAL PROCESS OF VALIDATION

Sayali Uday Budhavant*, Ketan Chandrakant Shinde, Ashwini Ramdas Sable and Sameer Dilip Pawar

ABSTRACT

The top objective of any pharmaceutical industry is to supply products of necessary characteristic and quality reliably, during a cost-effective manner. Development of a way is important for discovery, development, and evaluation of medicines within the pharmaceutical formulation. The main aim of this review article was to check the development and validation of the procedure employed for the medication from the starting of the formulation to the complete commercial batch of product. At the point when an analytical technique is applied to produce outcomes for the quality of medicine associated samples, it's necessary that the outcomes are reliable. In the Pharma industry, validation policy is documented for a way to perform validation, sorts of validation and validation policy are complied with the necessities of excellent manufacturing practice (GMP) regulations. Validation is extremely important for the effective running of the pharmaceutical firms. At every stage from staple to the finished, stability, everywhere validation was performed. The method was developed properly, and validation parameters are explained in terms of accuracy, specificity, and precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability testing with the example of certain drugs. All validation parameters are utilized in the routine and stability analysis.

Keywords: Validation, Method development, Linearity, Robustness, Ruggedness, LOQ, LOD.


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