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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.

Product Details

Published:
06/01/2014
Number of Pages:
7
File Size:
1 file , 110 KB
Redline File Size:
2 files , 310 KB