Paper Key : IRJ************294
Author: Dhatrak Adesh Sahebrao
Date Published: 09 Nov 2024
Abstract
In the Pharmaceutical industry 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 Manage IN the pharmaceutical indument (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistical tools in combination allows for a risk-based approach towards quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need them most.Evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the safety of the patient. For any pharmaceutical organization, quality risk management should aim at raising the level of protection for the patient, by reduction of the risk to which that patient is exposed at the time heshe receives a drug product. All kinds of quality, quality risk assessment, and also the risk management have been covered with extreme detail through the seminar report in the current scenario.