ASTM E2537

Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing

Standard · ASTM
ASTM E2537

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1.1 This guide describes Continuous Quality Verification (CQV) as an approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated and adjusted (as necessary). It is a science-based approach to verify that a process is capable and will consistently produce product meeting its predetermined critical quality attributes. CQV is similarly described as Continuous Quality Assurance (U.S. FDA) and Continuous Pro

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