Abstract

Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. The study presented here provides the assurance that the manufacturing procedure is suitable for intended purpose and the product consistently meets predetermined specifications and quality attributes, as per specified master formula record. It also provides documented evidence for the operation sequence of manufacturing process and to determine the critical parameters and variables in the process of manufacturing of the tablets.

Keywords

Process validation, Tablets, Quality, Validation Protocol, Manufacturing Process

Cite This Article

Patel, A. K. , Vekariya, C. N., Chauhan, R. S., Shah, S. A. (2013). Process Validation of Cefuroxime Axetil Film Coated Tablets, International Journal for Pharmaceutical Research Scholars (IJPRS), 2(2), 79-92.