Impact of the New EU Annex 1 on Lyophilization in the Pharmaceutical Industry
EducationalHow to manage the revision of cGMPs Annex 01 for sterile products
2025-06-04 | 01:20 PM - 01:35 PM | TPD Room
Information
This presentation provides an in-depth overview of the revised EU Annex 1, highlighting key differences between the 2008 and 2022 versions. It explores the impact of these changes on process design and equipment, focusing on validation and revalidation strategies for lyophilizers. Additionally, it covers best practices for conducting media fills in lyophilization processes and offers insights into CCS implementation. The discussion will also address regulatory and compliance challenges, ensuring a comprehensive understanding of the evolving requirements.
