Process capability indices (PCIs) have long served as crucial metrics in assessing the performance and quality of manufacturing processes. Recent advances in statistical estimation techniques have not ...
Performance metrics for processes are an area of much regulatory interest currently. There isn’t always a readily available clear definition of what is needed, however, and guidance from regulators is ...
This study examines the use of process capability index results to establish sampling strategies for new product cleaning and to minimize the risk of insufficient cleaning. Pharmaceutical development ...
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