Practical Risk Assessment for Process Design in a Virtual Development Environment

ICH Q9 provides a guideline on the use of quality risk management during product development, but during pharmaceutical development we are expected to be able to evidence the rationale of our decisions to determine what is critical and what is not critical to manufacture our products. This presentation provides an overview of which risk management tools are used by Shire Pharmaceuticals during process design and scale-up stages to ensure consistent product quality for the patient. The use of risk assessment tools and their suitability to different stages in the product development cycle and their practicality in a company operating in a fully outsourced R&D and commercial manufacturing environment is discussed. The principles described will be illustrated in a worked example from a project in Shire’s product development portfolio.