Does anyone know of any references that clearly outlines to the user what validation parameters need to be validated for the following types of method:
1)"In-house" & Compendial HPLC methods
2) Spectrophotometric methods such as UV-Vis, AA, ICP & NIR
3) TLC & Titration methods
![]()
![]()
![]()
![]()
By Wanda on Thursday, April 24, 2003 - 10:54 am:
If the in-house methods are used to release product, this is a good reference: http://www.waters.com/WatersDivision/waters_website/Applications/validate/Vldt_top.asp
I believe for compendial methods, a method transfer/evaluation (described in the above article) is indicated. Or check the USP VALIDATION OF COMPENDIAL METHODS
ICH guideline Q2 deals with analytical validation: http://www.ich.org/ich5q.html
![]()
![]()
![]()
![]()
By wanda on Thursday, April 24, 2003 - 10:54 am: