INDUSTRIAL PROCESS VALIDATION OF TABLETS: AN OVERVIEW

Abstract

The validation is a Fundamental segment to support the commitment of company towards quality assurance. It also assures that product meets its predetermined quality specification and quality characteristics. Validation of individual steps of manufacturing is known as process validation. Product quality is the mainstay of pharmaceutical industries and is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and manufacturing process design, control of the process variables, in-process and end-product testing. By validating each step of production process we can assure that the final product is of best quality & provides information on validation of tablet dosage form which has a numerous advantages over other dosage forms.  The objective is to present a review and to discuss aspects of validation in terms of pharmaceutical unit operations like those individual technical operations that comprises of various steps involved in product design and evaluation and provide information on validation of tablet dosage form which have numerous advantages over other dosage forms.

 KEY WORDS: Quality, process variables, process validation, manufacturing, dosage forms, guidelines.