Analytics continues to be a challenging area for GMP compliance and the number of warning letters that are focused on this area continue to increase . Non-compliance to USP feature prominently in the 483s issued. Laboratory staff continues to have questions about the difference between method Validation and Verification and the conditions under which these two different concepts need to be applied.
This webinar will provide an in-depth discussion of USP , 'Verification of Compendial Methods' requirements. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations. Conditions under which Methods can be classified as 'basic' and not require verification will be discussed. The factors under actual conditions of use which impact method performance and make method verification necessary will be addressed. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations on which compendial methods needs to be verified.