Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. Per ICH Q8, the aim of ...
Critical process parameters (CPPs) and their associated process controls are crucial to drug development and process validation and to the evaluation of every manufacturing unit operation. "…. These ...
CP is a common measure used in process capability analysis. It allows you to know how well your process is meeting your customers’ expectations and specifications. This article will explain how CP is ...
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