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ASTM E2898-14 + Redline
Standard Guide for Risk-Based Validation of Analytical Methods for PAT ApplicationsMore info
1.1 This guide provides an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation.
| Author | ASTM |
|---|---|
| Editor | ASTM |
| Document type | Standard |
| Format | File |
| ICS | 11.120.99 : Other standards related to pharmaceutics |
| Number of pages | 7 |
| Replace | ASTM E2898-13 + Redline |
| Set | ASTMVOL1405 |
| Year | 2014 |
| Document history | ASTM E2898-13 + Redline |
| Country | USA |
| Keyword | ASTM 2898;ASTM E2898;ASTM E2898;10.1520/E2898-14 |