Abstract

PREPARATION AND PROCESS VALIDATION OF METFORMIN HYDROCHLORIDE TABLET

Dr. Abhishek Kumar Rai*, Dr. Rajeev Kumar Shukla and Kaushal Kumar Yadav

ABSTRACT

The prime objective of any pharmaceutical plant is to manufacture products of requisite attribute and quality consistently at the lowest possible cost. Validation is a concept that has evolved in States in 1978. The concept of validation has expanded through the years to embrace a widerange of activities from analytical methods used for the quality control of drug substances and drugproducts to computerized systems for clinical trials, labeling or process control, Validation isfounded on, but not prescribed by regulatory requirements and is best viewed as an important andintegral part of cGMP. The basic concept has longbeen applied in other industries, often without formal recognition that such a concept was beingused. The end of the sequence that has been assigned to process validation is derived from the fact thatthe specific exercise of process validation should never be designed to fail. Failure in carrying outthe process validation assignments often the result of incomplete or faulty understanding of theprocess’s capability, in other words, what the process can and cannot do under a given set of operational circumstances.

Keywords: Metformin hydrochloride, sodium starch glycolate IP, starch IP, Purified water, polyvinyl pyllrolidone IP.