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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 |