CURRENT CHALLENGES IN PROCESS VALIDATIONS

P. Swetha*, M. Karthik and Dr. G. Sandhya Rani

ABSTRACT

From the study, it can be stated that current challenges in process validation is a major requirement of cGMP regulation for finished pharmaceutical products. It is a key element in assuring that the quality goals are met. Successfully validating a process may reduce the dependence upon intensive in process and finished product testing. Finally, it can be concluded that Process validation is a key element in the quality assurance of pharmaceutical product as the end product testing is not sufficient to assure quality of finished product.

Keywords: current challenges in process validation, pharmaceutical product.