How RTU Solutions Can Meet GMP Annex 1 Requirements

The current EU GMP Annex 1 emphasizes the importance of handling critical manufacturing steps and managing risks associated with contamination. It is crucial for pharmaceutical companies to align their quality management system and establish appropriate Contamination Control Strategy (CCS) and Quality Risk Management (QRM).

By choosing Ready-To-Use (RTU) containers, pharma companies can remove critical operating units and significantly automate their manufacturing process and reduce human intervention, minimizing potential risks of contamination connected to the washing and depyrogenation phases, making operations leaner, and allowing pharmaceutical companies to focus on key activities with the most added value.

In this webinar we discover how Stevanato Group’s RTU containers can be a smart solution to aseptic manufacturing challenges, meeting regulatory requirements and reducing the risk in client’s operations throughout the process with EZ-fill® platform, a fully integrated pre-washed and pre-sterilized containment solution for aseptic manufacturing.

We will deep dive into the benefits for Pharma Companies of adopting RTU solutions:

• Reduced contamination sources
• Reduced Total Cost of Ownership – simplified CCS implementation and reduced costs of Isolation Technology
• Preserved container quality for patients’ safety