An Inside Look at USP 71

This session will provide an inside look at the requirements set forth in USP 71 with respect to sterility tests. We will review sampling requirements for method suitability and sterility testing utilizing Tables 2 and 3. Attendees will learn how to interpret the Certificate of Analysis (CoA) and how different sample types respond to sterility testing. Also, we will explain what is required to validate alternative sterility test methods.

Learning Objectives:
1. Examine USP 71 method suitability and testing sample requirements
2. Evaluate different sample types response to sterility testing
3. Interpret Certificate of Analysis
4. Identify current regulatory landscape of alternative sterility test methods