Top Ten List of Analytical Inadequacies in IND and BLA Submissions

Today, we feature a presentation from the 2013 Well Characterized Biologicals event. Last year, Alfred Del Grosso, Team Leader, Analytical Chemistry at FDA/CBERTop presented Ten List of Analytical Inadequacies in IND and BLA Submissions.

So what are the Top Ten List of Analytical Inadequacies in IND and BLA Submissions?
1) Procedural Details
2) System Suitability Tests
3) Representative Instrumental Outputs
4) Types of Validation Characteristics / Test Categorization
5) Linearity in Matrix
6) Verification of “Compendial” Procedures
7) Robustness of Critical Assay Parameters
8) Accuracy Calculations
9) Evaluation of Range
10) Choice of Factors in Intermediate Precision

Why?  Download Del Grossso's full presentation here.

This year's perspectives from the FDA come from Lokesh Bhattacharyya, Ph.D., Lab Chief, Laboratory of Analytical Chemistry and Blood Related Products, Division of Biological Standards and Quality Control, CBER, U.S. FDA in the presentation New FDA Draft Guidance on Analytical Procedures and Analytical Method Validation for Drugs and Biologics.  For more information on this session, download the agenda.  If you'd like to join us November 3-4 in Washington, DC for the Well Characterized Biologicals event, as a reader of this blog when you register to join us and mention code XD14193BLOG, you can save 20% off the standard rate.

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Session Spotlight: Top 10 List of Analytical Inadequacies in IND or BLA Submissions

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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