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Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1

A Science-Based Holistic Approach
 

The revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products, was finalized on 25 August 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, a science-based holistic approach to ensure good CCI and include a description of CCIT methods that can be used for frozen products needing cold chain storage and transport.

 

  1. Learn in detail how the new requirements of the revised EU Annex 1 may impact your strategy for ensuring the container closure integrity (CCI) of sterile pharmaceutical products.
  2. Gain understanding of the advantages and disadvantages of container closure integrity testing methods and why a science-based holistic approach to ensure good CCI is important.
  3. Learn how cold chain storage and transport can impact the CCI of sterile pharmaceutical products.

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