Achieving Manufacturing Process Excellence

Successful approaches to moving towards real-time quality assurance require that the Critical Process Parameters (CPP) driving variability in the Critical Quality Attributes (CQA) be identified and understood during process development so that they can be measured and controlled in real-time during the manufacturing process. This is what the FDA means by "Process Understanding." It requires a culture of continuous improvement without the need for regulatory intervention to approve changes, and close collaboration between the process development and manufacturing teams along with deployment of appropriate enabling technologies. As an added benefit, this collaboration has the potential to drive the adoption of better practices and sustain the business benefits of higher levels of process predictability and quality compliance across the entire global manufacturing network.

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