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ASTM E2537-16

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ASTM E2537-16

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

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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.

Author ASTM
Editor ASTM
Document type Standard
Format File
ICS 03.120.10 : Quality management and quality assurance
11.120.01 : Pharmaceutics in general
Number of pages 5
Replace ASTM E2537-08
Set ASTMVOL1405
Year 2016
Document history ASTM E2537-08
Country USA
Keyword ASTM 2537;ASTM E2537;ASTM E2537;10.1520/E2537-16