Meet Pharmacopeia and Annex 1 Requirements - 2025

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Is Your Online TOC Analyzer Ready to Meet Pharmacopeia and Annex 1 Requirements?


Understanding the requirements set forth by the US and European Pharmacopeias for the analysis of Total Organic Carbon (TOC) in Purified Water (PW) and Water for Injection (WFI) is crucial for ensuring compliance and maintaining high standards in pharmaceutical water systems. Additionally, the impact of the Annex 1 of the European Union’s Good Manufacturing Practices (EU GMP Annex 1) guidelines on the monitoring of WFI systems introduces new challenges and considerations for maintaining compliance.

This webinar will review the specific requirements of the US and European Pharmacopeias and of EU GMP Annex 1, and what they mean for TOC analysis. We will explore various TOC analysis technologies and how they meet these requirements, with a focus on the advanced capabilities of the PAT700 TOC Analyzer.

This session will demonstrate how the PAT700's innovative technology ensures seamless compliance with all relevant requirements, offering a reliable solution for your TOC analysis needs.

Learning Objectives

• Learn about the requirements of US and European Pharmacopeias for the analysis of Purified Water and Water for Injection.
• Learn about the impact of Annex 1 on WFI systems monitoring.
• Understand how the PAT700 Online TOC Analyzer helps you to comply with all these requirements.

Speaker

Matthieu Chausseau, Ph.D.

Senior Technical Product Manager

Beckman Coulter Life Sciences