Abstract

Sirisha Pasupuleti*, G. Sushma Reddy and S. Supriya

ABSTRACT

Quality assurance functions primarily to monitor the fact that the quality function is being performed. Its role in process validation is readily associated with its main functions. Validation has become one of the pharmaceutical industries most recognized subjects. Validation is the art of designing and practicing the designed steps alongside with the documentation. Validation and quality assurance will go hand in hand, ensuring the thorough quality for the products. It analyzes the product complaints to learn how effective its test program has been in preventing rejectable product from reaching the market place. According to GMP validation studies are essential part of GMP these are required to be done as per predefined protocols, the minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. The validation study provide the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Thus validation is an essential part of quality assurance.