1 . 6 Enablers: Knowledge Management and Quality Risk Management

Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully .These enablers will facilitate achievement of the objectives described in Section 1.5 above by providing the means for science and risk based decisions related to product quality .The size and complexity of the company’s activities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one The design of the pharmaceutical quality system should incorporate appropriate risk management principles.