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ASTM E2537 PDF
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Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
| Published by | Publication Date | Number of Pages |
| ASTM | 12/01/2016 | 5 |
ASTM E2537 – Standard Guide forApplication of Continuous Process Verification to Pharmaceuticaland Biopharmaceutical Manufacturing
1.1 This guide describes Continuous Process Verification as an alternate 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. Continuous Process Verification (ICH Q8) is similarly described as Continuous Quality Verification.
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