Procedures to support the identity, strength, quality, purity and potency of drug products and drug substances are an important component of new product applications reviewed by the FDA. Inadequacies commonly encountered in these submissions involve procedural details, system suitability tests, representative instrumental outputs, types of validation characteristics, linearity in sample matrix, verification of “compendial” procedures, robustness of critical assay parameters, accuracy calculations, precision and accuracy across intended range and factors in intermediate precision. So what exactly are the FDA expectations for analytical procedures and validations? Session: Top 10 List of Analytical Inadequacies in IND or BLA Submissions
Speaker: Alred Del Grosso, Team Leader, Analytical Chemistry, CBER, US FDA
Join us for IBC's 17th Annual Well Characterized Biologicals as we highlight some of the errors and inadequacies FDA regulators have seen over the years in submissions. To learn more about our program, download the agenda.
As a reader of this blog, use code XB13193BLOG and save 15% off of the standard rate when you register. We look forward to seeing you October 21-23 in Washington, DC!
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