Abstract

A REVIEW ARTICLE ON: PHARMACEUTICAL VALIDATION

Supriya Subhash Jadhav* and Manure Md. Javeed Md. 

ABSTRACT

Validation is the skill of properly creating and practicing the designed steps using documentation. The process validation provides documented evidence to assure that a particular Method consists of producing a product that follows the defined requirement and quality characteristics. Validation of the procedure for the drug product from the formulation Devlopment stage to the commercial batch. Creation of method for the interested portion in Pharmacy product completed product or process tests, sample preparation, and providing a realistic approach for estimating the selectivity, specificity, detection of limit, quantity limit, linearity, accuracy of the range, precision, consistency of the recovery solution, robustness and robustness of liquid chromatographic methods. Legality is therefore an essential component of quality assurance and pharmaceutical chemistry.

Keywords: Standard Operating Procedures, Process Qualification, Operational Qualification, Limit of Quantitation, Limit of Detection.