From Compliance To Confidence: Annex 1 For Small-Batch, High-Value Production

The updated GMP Annex 1 introduces significant new challenges, especially for manufacturers handling small-batch, high-value products like ATMPs, orphan drugs, and personalized medicines. Successfully navigating these requirements demands a clear understanding of compliance without resorting to unnecessary over-engineering. This session provides a practical roadmap for interpreting and applying Annex 1 within a real-world fill-finish environment.

You'll gain expert insight into regulatory expectations for a robust Contamination Control Strategy (CCS), equipment design, and process monitoring. The discussion will specifically examine the differences in environmental monitoring for liquid vs. powder aseptic filling and best practices for quality management and reject handling. To illustrate these concepts, you'll see a live demonstration of an advanced, isolator-based small-batch aseptic fill-finish system that helps meet these heightened compliance standards with greater control.

View the full webinar to understand how to achieve risk-based Annex 1 compliance while maintaining efficiency for your high-value products.