Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1: A Science-Based Holistic Approach

Science-based holistic approaches to help sterile product manufacturers follow new container closure integrity requirements set forth by the revised EU Annex 1 for cold chain storage and transport.

Register Free: https://www.pharmtech.com/pt_w/revised-eu-annex

Event Overview:

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.

Speakers:

Featured Speaker
Director
LIGHTHOUSE Instruments

Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for 100% container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.

Register Free: https://www.pharmtech.com/pt_w/revised-eu-annex