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:
- 11/01/2013
- Number of Pages:
- 7
- File Size:
- 1 file , 120 KB
