From Compliance to Confidence: Annex 1 for Small-Batch, High-Value Production
Upcoming Webinar: From Compliance to Confidence: Annex 1 for Small-Batch, High-Value Production
Join us for an exclusive live session showcasing 3P innovation’s Robotic Fill-Finish Cell: roboFIL, a fully flexible, Annex 1–ready platform designed for both liquid and powder applications.
Date: 3rd October / 11am ET
Format: Remote
Sign up here: https://bit.ly/4pacYek
What to expect?
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’ll 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.
Join Pharmaceutical Online with Tracy Moore, Principal Consultant at TM Pharma and former MHRA inspector, who will provide expert insight into regulatory expectations and practical approaches. The webinar will include:
- 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
To support the discussion, 3P innovation will present a live demonstration of roboFIL®, their latest small-batch aseptic fill-finish system. The session will show how advanced automation and isolator-based design can help meet Annex 1 expectations with greater confidence and control.
This is a must-attend session for drug manufactures, in particular, QA leaders, validation specialists, engineers, and regulatory teams involved in aseptic manufacturing or planning Annex 1 readiness strategies.
