From Compliance to Confidence: Annex 1 for Small-Batch, High-Value Production
3P innovation’s Robotic Fill-Finish Cell: roboFIL, is a fully flexible, Annex 1–ready platform designed for both liquid and powder applications.
Navigating GMP Annex 1 updates has raised new challenges - especially those working with small batch, high-value products in emerging fields like ATMPs, orphan drugs, and personalised medicines.
This webinar explores how to interpret and apply Annex 1 in real-world fill-finish environments, with a particular focus on aseptic filling of small-volume liquid and powder products. We examine key requirements for contamination control strategies (CCS), environmental and process monitoring, equipment design, and reject handling - all essential for ensuring compliance while maintaining flexibility and efficiency in production.
Tracy Moore, Principal Consultant at TM Pharma and former MHRA inspector, provides expert insight into regulatory expectations and practical approaches. The webinar includes:
- Differences in environmental monitoring requirements for liquid vs powder aseptic filling
- Quality management approach and reject handling
- How to approach risk-based compliance without over-engineering
