-
- Posts: 520
- Joined: Fri Feb 10, 2012 7:39 pm
The question is: do our QC test procedures for the incoming API need to be validated (or use the USP assay procedure), or just to show that the incoming material meets our own company standard of quality - as we do not sell the API, just finished goods containing that API? And those API materials are already certified by their manufacturer as meeting USP requirements.
We develop and validate our own test procedures for the API in the finished products (what we actually sell) as per ICH/USP/cGMP etc.
Thanks.