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INDUSTRIAL PROCESS VALIDATION OF TABLET DOSAGE FORM: AN OVERVIEW

Keywords: Process validation , Tablet dosage form , Quality assurance , Protocol , Regulatory basis , Wet granulation.

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Abstract:

In pharmaceutical organizations, validation is a fundamental segment that supports a company commitment to quality assurance. Validation is a tool of quality assurance which provides confirmation of the quality in equipment systems, manufacturing processes, software and testing methods. Validation assures that products with pre-determined quality characteristics and attributes can be reproduced consistently/reproducibly within the established limits of the manufacturing process operation at the manufacturing site. Validation of the individual steps of the manufacturing processes is called the process validation. Different dosage forms have different validation protocols. Here this article concentrates on the process validation of tablet dosage form, protocol preparation and regulatory basis for process validation in industry. It gives in detail the validation of each step of the manufacturing process of tablets through wet granulation.

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