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Author: MTS
A Wish List for ICH Q2(R2), the Revision of the Guideline on Method Validation
The ICH guideline on method validation, Q2 (R1) [1], is currently being updated and I thought it might be interesting to put together a wish list for the changes that I would like to see in the new version. Rather than a wide-ranging treatment of all analytical method validation related issues, such as how it […]
Strategies for HPLC Method Development
Webinar Recording This webinar explored the different strategies, and combinations of strategies, which may be applied during HPLC method development. The best approach may vary depending on the particular requirements for a given separation. Related content from our Resources Library
Where do the Acceptance Criteria in Method Validation Come From?
Webinar Recording One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance criteria, particularly for the characteristics of accuracy and precision. It sometimes seems that the values are just plucked out of the air! Available guidance documents, such as ICH Q2(R1), don’t mention any numbers. In this […]
5 Golden Rules for Effective (and Inspection Ready) OOS Investigations
The investigation of out of specification (OOS) results is a regulatory requirement in a GMP laboratory and these investigations are intensively scrutinised by health authority inspectors. The purpose of this article is to provide 5 ‘Golden Rules’ which will make sure that investigations are both effective and inspection ready. Rather than use the term OOS […]