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.
Product Details
Published:
06/01/2020
Number of Pages:
7
File Size:
1 file , 110 KB
Redline File Size:
2 files , 220 KB
Note:
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