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Activity Number: 304
Type: Topic Contributed
Date/Time: Tuesday, August 2, 2016 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #320755 View Presentation
Title: Bayesian Assurance and Sample-Size Determination in the Process Validation Lifecycle
Author(s): Paul Faya* and John W. Seaman, Jr. and James D. Stamey
Companies: Baylor University and Baylor University and Baylor University
Keywords: pharmaceutical ; manufacturing ; process ; validation ; Bayesian ; batches

Validation of a pharmaceutical manufacturing process is a regulatory requirement and establishes scientific evidence that the process is capable of consistently delivering a quality product. The FDA guidance on process validation recommends a life-cycle approach encompassing process design, qualification, and verification. Determining the number of batches to be used for the qualification stage is a major challenge faced by manufacturers. A successful process qualification is required before commencement of commercial distribution of the drug product. We present a Bayesian assurance and sample size determination approach where prior process knowledge and data are used to inform the qualification stage. An example is presented in which drug potency data is evaluated using a process capability metric. Qualification data are simulated using the posterior predictive distribution and the decision on the number of batches is made based on a desired level of assurance.

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

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