ICH Guidelines 733 * Corrective action and preventive action (CAPA) system: complaints, product rejections, recalls, non-conformances, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring should be properly investigated. Based on these reports corrective and preventive actions should be taken. * Change management system: to ensure continuous improvement in a timely and effective manner and to achieve a high degree of assurance of the product quality, changes in the systems and processes are required. This is executed by the change management system. * Management review of process performance and product quality: The results of regulatory inspections and findings, audits and other assessments, and commitments made to regulatory authorities, extent of customer satisfaction with respect to the product quality, etc. are to be reviewed periodically and corrective actions are to be taken. Effective and successful implementation of ICHQ10 in a pharmaceutical industry is possible through Knowledge Management and Quality Risk Management. For this these are termed as Enablers. The achievement of the abjectives of ICHQ10 described above can be facilitated by these enablers that provide the means for science and risk based decisions related to product quality. Knowledge Management Knowledge management is a systematic approach to acquire, analyze, store and disseminate information related to products, manufacturing processes and components. When the activities starting from development to commercialization of a product and even up to the product discontinuation are managed using scientific approaches (knowledge), it provides knowledge and proper understanding about the product. Sources of knowledge may be prior knowledge (public domain) or internally generated through pharmaceutical development studies; technology transfer activities; process validation studies; manufacturing experience; innovation; continual improvement; and change management activities. Quality Risk Management Quality risk management is a very much essential part of an effective pharmaceutical quality system, It can provide a proactive scientific approach to identify, evaluate and contral the potential risks to quality. It helps continuous improvement of process performance and product quality throughout the product lifecycle. ICH Q9 provides principles and examples of tools for quality risk management. These can be applied to different aspects of pharmaceutical quality. Ul O <