P.R. Khuspe

In the pharmaceutical industry today, there are some examples of the use of quality risk management but, they do not represent the full contributions that risk management has to offer. Quality risk assessment is a process of identification of hazards, analysis and evaluation of the risks associated with exposure to those hazards. Risk assessment is a main part of quality risk management process. The 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 he/she receives a drug product. In the present seminar report all the aspects regarding quality, quality risk assessment and risk management are covered in great detail.