RISK ASSESSMENT APPROACH AND ITS APPLICATION IN PHARMACEUTICAL INDUSTRY FOR PRODUCT QUALITY MANAGEMENT

Singh U. K.* Pahwa Shilpa, Sethi Vandana

School of Pharmacy, Lloyd Institute of Management and Technology, Plot No. 11, Knowledge Park II, Greater Noida 201310 (U.P.), India

ABSTRACT

With the introduction of FDA’s 21st century GMP and ICH initiatives (such as Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System), drug manufacturing entered a new era of risk management. Quality risk management is a process for assessment, control, communication and review of risk to the quality of the medicinal product. It can be applied both proactive and retrospectively. For any pharmaceutical product, Quality Risk Management shall be applied to aim that raising the level of protection for the patient by the reduction of the risk to which that patient is exposed at the time he /she receives a drug product. This general objective can only be achieved by implemented policy of quality risk management on the product and process design and its lifecycle. The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Information from pharmaceutical development studies can be a basis for quality risk management. It is important to recognise that quality cannot be tested into products; i.e., quality should be built in by design.

Keywords:

Quality risk management, Risk Prioritization Number