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Ranjana Suryawanshi?, Aparark Mohalkar, Radhabai Jadhav, Manjusha Bhange, Ashwini Jankar


The purpose of Quality Risk Management is to illustrate practical ways to analyze the risks to quality system, providing guidance along the way to achieving effective and efficient quality management and compliance. In the pharmaceutical manufacturing every product and every process associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in -recent guidance as a combination of the probability of occurrence of harm and the severity of that harm. The Quality Risk Management (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistical tools in combination allows for a risk-based approach to quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need them most and proactive approach to compliance of good manufacturing practices (GMP). This article aims to provide principles and examples of tools for Quality Risk Management (QRM) that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, inspection and submission of review processes throughout the lifecycle of drug substances, drug products and biological products.

Keywords: Quality Risk Management, Risk assessment, Tools, Methods, Process, FMEA, Probability, Severity, ICH, GMP.

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