Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Seth Schulte, MS
Biologist
Division of Biological Standards and Quality Control (DBSQC)
Office of Compliance and Biologics Quality (OCBQ)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Seth Schulte, MS is a Biologist in the Division of Biological Standards and Quality Control, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research. Prior to his work at FDA, Seth worked in various industry settings in quality control, analytical development, and small-scale production. Since joining FDA in 2021, Seth has been involved in the operation of the lab clean suite, execution of sterility testing, and regulatory review of microbiological methods for multiple FDA offices.
Abstract
Seth Schulte of CBER presents on the evaluation and implementation of rapid microbial methods (RMMs), also known as alternate microbiological methods. RMMs offer the significant advantage of providing test results much faster than traditional 14-day compendial methods. Implementing an RMM requires demonstrating method suitability under the actual conditions of use, specifically in the presence of the product. Furthermore, method validation of the alternate method is a regulatory requirement, necessitating the assessment of multiple validation parameters such as accuracy, sensitivity, specificity, reproducibility, limit of detection, ruggedness, robustness, and equivalence. The presentation emphasizes that equivalence testing must demonstrate that the alternate method provides assurance that is equal to or greater than the compendial standard method. Key guidance documents like USP1223 and European Pharmacopoeia 516 offer valuable detail for validation. It is crucial to distinguish between primary validation, often performed by the supplier without the product, and validation for intended use, which the end user must perform in the presence of their specific product. Special considerations and risk-based approaches may be necessary for products with challenges like limited sample size or short shelf life. CBER strongly encourages manufacturers considering RMMs to reach out for feedback and guidance early in the process.