By Marina on Monday, May 17, 1999 - 04:00 pm:
We've just developed a new HPLC method and we need to validate it. Where can we get some ideas about what steps need to be taken in method validation and how we should go about it?
By Steve on Monday, May 17, 1999 - 05:02 pm:
Validation guidelines have become pretty industry-specific these days. For whom will you validate your new method?
By hinsbarlab on Tuesday, May 18, 1999 - 08:33 am:
A good source is USP 23 , pg. 1982. Also FDA Guidance Documents ICH-Q2B and ICH-Q2A, "Validation of Analytical Procedures: Methodology" and "Text on Validation of Analytical Procedures," respectively. Available from the FDA's web site at:
http://www.fda.gov/cder/guidance/index.html
Regards,
Michael Hinsberg
Hinsbar Laboratories, Inc.
www.hinsbarlabs.com
By Ted Heise on Tuesday, May 18, 1999 - 11:47 am:
An additional FDA guidance is CMC 3, titled "Reviewer
Guidance - Validation of Chromatographic Methods"
By Stephen Moore on Tuesday, June 1, 1999 - 07:29 am:
Most regulatory bodies including the Pharmacopoeias (USP in the States, Ph Eur in Europe) are accepting ICH (International Council for Harmonisation) guidelines for method validation. For HPLC these should include linearity, precision, accuracy, ruggedness, limits of detection/quantitation and selectivity. The limits on these tests will depend on the performance of your method and the samples to be routinely analysed.
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