Critical Quality Attributes, Critical Process Parameters ...
Procedure – Tracking/Trending ¾Written SOPs with Pre-defined}Metrics, Data, Parameters, Attributes}Frequency of Evaluation}Evaluation Methods (Statistical Analysis) Statistical Process Control Softwares, Trends Data of Exception (Exceeding Alert or Action Limits)}Actions to be Taken (CAPA) 19 Biologics Quality & Regulatory Consultants, LLC
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