关于进一步深化“五好党支部”创建与.pptVIP

Quality by DesignThe Challenge for Regulators Summary of New Thinking Path for Development of Review Considerations Not yet FDA policy Overview The traditional system of approval and change control seems burdensome There should be a way to protect the public without slowing innovation Methods and standards for this are available Need to train ourselves into a new way of thinking and working Shared Concerns The pharmaceutical industry has one of the most technically advanced discovery organizations, but remains more conservative when it comes to using cutting edge technology in manufacturing. Concern over how regulatory agencies will react to technology. Agency study of potentially inconsequential impact on the product can result in delay. Potential for Contradiction Commitment to high quality products with Commitment to most rapid introduction to market Inclusion of development data helps, but can not equal knowledge obtained during routine production When to Optimize the Process Optimization before approval Greatest cost may be time No baseline for measuring return on investment Provides immediate benefit to patient Continuous improvement Time element minimized Enables measured improvement Feed forward data and scope protocols Points to Consider Raw Materials Process Measurement Steering the Process Variability Raw Materials Pharmaceutical raw materials are variable. Cannot assume that holding the inputs constant will always produce a constant product. Ergo: Attempting process control through raw material control is futile.  Process Discovery and Design suggest a process. You need to measure and model the process then steer it. The model should be designed so that we can measure the parameters used in the model to control the process. As the model evolves measurement strategy evolves with it. There is a lack of process models in applications Measurement Measurement is most effective when used to control the process in “real time”. Traditional approa