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- Posts: 17
- Joined: Fri Mar 12, 2010 4:27 pm
- Location: michigan
I got a strange situation with my method, which was originally validated and submitted to regulatory. Now with the same method samples are assaying about 95% and I need to increase 5% of the organic content of the sample diluent to get 100% assay.
Do I need to do full validation for this change? where can I find the guidance related to this? Please advise if you know. Thanks.