Event Concluded
Pharmaceutical Technology
Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1: A Science-Based Holistic Approach
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Webinar
Feb 28, 2023
EST|8am PST|4pm GMT|5pm CET
About Event
The revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products, was finalized on August 25, 2022, and includes new requirements for ensuring the container closure integrity (CCI) of sterile pharmaceutical products. This webinar will present how sterile product manufacturers can prepare themselves for the new regulations using a science-based holistic approach to ensure good CCI, and includes a description of CCIT methods that can be used for frozen products needing cold chain storage and transport. Key Learning Objectives Learn in detail how the new requirements of the revised EU Annex 1 may impact your strategy for ensuring the container closure integrity of sterile pharmaceutical products. Gain understanding of the advantages and disadvantages of container closure integrity (CCI) testing methods and why a science-based holistic approach to ensure good CCI is important. Learn how cold chain storage and transport can impact the container closure integrity of sterile pharmaceutical products.
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