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ASTM E2898-14

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ASTM E2898-14

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

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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
Set ASTMVOL1405
Year 2014
Document history ASTM E2898-13
Country USA
Keyword ASTM 2898;ASTM E2898;ASTM E2898;10.1520/E2898-14