Pharmaceutical Quality Risk Management System: Current Concept

Every product and every process has an associated risk. Every enterprise should have a methodology for identifying and evaluating the risks it faces and it should have a process for generating intervention plans to reduce the risks to an acceptable level. This process is generally referred to as a Risk Management Plan (RMP)Pharmaceutical Industry being an important industry which is directly related to the health of people in society hence risks associated with the Pharmaceutical Industry are need to be evaluated. Every pharmaceutical product and every process has an associated risk. As per ICH Q9, Risk is defined as Combination of the probability of occurrence of harm and the severity of that harm the word “risk” is widely used in general and technical applications with different Meanings. Every product and every process has an associated risk.
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.