Abstract

REVIEW ON BASIC CONCEPTS OF PROCESS VALIDATION AND PROCESS CONTROL

Pankaj Dattatray Dhage*, Dr. Sameer Shafi, Avinash Swami, Pradip Landge, Vishweshwar Dharashive

ABSTRACT

Validation is a technique of designing and practicing the designed steps along with the documentation. Quality is that the primeval intention of any trade and its product factory-made. Multiple views on getting such quality square measure this interest within the pharmaceutical trade, and it's been maintained by validation. Validation is documented proof that has a high degree of assurance. Validation is one amongst the necessary steps in achieving and maintaining the standard of the ultimate product. If every step of production method is valid, we will assure that the ultimate product is of the most effective quality. Validation is that the art of coming up with and active the designed steps aboard with the documentation. This review covers scope of validation, history and kinds of validation. The validation study gives the accuracy, sensitivity, specificity and duplicability of the take a look at strategies utilized by the corporations, shall be established and documented. so, the validation is an important a part of the standard assurance.

Keywords: Quality, Validation, Protocol.