Modern Risk Based Approaches

In recent years, the concept of quality is transforming. Product quality and performance are achieved and assured through effective designing and efficient manufacturing processes. ICH guidelines provide the foundation to the modern risk-based approaches to pharmaceutical quality and manufacturing (340). Risk, quality, and uncertainty are very broad concepts and are not suitable for formal analysis until they are well defined within a specific concept (341). These approaches have influenced both industry and regulatory agencies worldwide (342).

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