Knowledge Management and Risk Assessment for Life Cycle Stages
The foundation of pharmaceutical development is knowledge and understanding. However, the general knowledge is not sufficient for making scientifically sound decisions for the specific product, but rather a starting point of product development. International Conference on Harmonization (ICH) Q9 provides a systematic approach to quality risk management. It gives the principles and tools of quality risk management to make risk-based critical decisions in process validation life cycle. The tools proposed are recognized across the industry for risk management purposes. Assessment of risk to quality is based on sound scientific knowledge and based on patient impact. FDA process validation guidance highlights the need to using risk-based decision-making. The level of risk assessment is determined by the complexity of the scenario. Quality risk management tools are enabling tools (Stocker et al., J Pharm Sci 106:278–290, 2017). Selection of fit for purpose tools (Strong, The risk of trusting risk priority numbers. AAPS Newsmagazine, 2017) and use of the appropriate tools are critical at each stage of the process validation life cycle.
KeywordsKnowledge management Product development Risk assessment Knowledge space Process design
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