ASTM E2898 PDF
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Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
Published by | Publication Date | Number of Pages |
ASTM | 06/01/2020 | 7 |
ASTM E2898 – Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
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.
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