Quality risk assessment refers to the process of identification of hazards, analysis and evaluation of risk associated with its exposure. Once a potential risk is identified, then appropriate risk control strategies can be implemented to minimise the potential risks. Traditionally, risk assessment is an integral part of Good Manufacturing Practice guidelines from "The Pharmaceutical Inspection Cooperation Scheme (PIC/s)" and "European Medicines Agency (EMA)". Subsequently, the International

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... erence on Harmonisation published a series of guidelines to harmonise the requirements which covers Q1 which covers stability to Q11 which talks about development and manufacture of drug substance. This includes (ICH) Q9-Quality Risk Management which explains the systematic ways to perform risk assessments, and Q10-Pharmaceutical quality system which talks about control strategy and continual improvements in the product lifecycle. There are a handful of new guidelines and requirements in pipeline which affects the pharmaceutical industry in near future. ICH Q3D Guideline for Elemental Impurities will be implemented globally with in next few years and for this, a systematic risk assessment for risk due to elemental impurities is required to be conducted. Similarly, a new guideline by ICH for Pharmaceutical Product Lifecycle Management (Q12) will also ride on similar risk assessment principles. Therefore, there is a need to develop a holistic approach for product quality risk management which can be applied from development of control strategy to its maintenance as a part of life-cycle management of the medicinal product.During development, the risks from the materials, equipment and process development studies is considered for the development of a control strategy whereas in post approval, changes such as suppliers, equipment, process etc. can influence the product performance and risk profiles. There should be an adaptive risk assessment model which helps in continuous updating of the control strategy. This article is to provide an overview of changes happened in thequality risk assessment approach and its current applications during the development and lifecycle management of pharmaceutical products and continuously updating control strategy.