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Activity Number: 566 - Recent Advances in Quality Statistics and Process Validation of Pharmaceuticals
Type: Topic Contributed
Date/Time: Wednesday, August 2, 2017 : 2:00 PM to 3:50 PM
Sponsor: Section on Risk Analysis
Abstract #322765
Title: Process Validation: Statistical Methods for Evaluating Uniformity of Dosage Units
Author(s): James Bergum* and Thomas Stepinac
Companies: and Novartis
Keywords: Process Validation ; Content Uniformity ; ASTM ; Acceptance Criteria ; Tolerance Intervals
Abstract:

Provide a review of statistical sampling plans and methods used to collect and evaluate process validation content uniformity data. Methods discussed include ASTM E2709 and ASTM E2810 as well as two tolerance interval based methods. All methods provide acceptance criteria that, if met, will assure a high probability that a batch will meet the USP UDU < 905> Uniformity of Dosage Units test. Also, provide a summary of an USP Expert Panel that is addressing issues around the USP UDU test and working on a possible 1000+ USP informative chapter to discuss statistical methods that could be applied for batch release.


Authors who are presenting talks have a * after their name.

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