Importance of quality management system in current scenario

Abstract

A review was conducted by analysing many publications and they were concerned with the pharmaceutical quality directly and with the general quality practices. The content of those sources was analysed and some guidelines were identified which include WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines. Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, some topics were identified and reviewed like quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, out of trend, out of specification and HACCP.\