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 , 160 KB

Redline File Size:

2 files , 360 KB