The new EU GMP Annex 1 contains new requirements for the container closure of sterile pharmaceutical products. These requirements will trigger new best industry practices in the area of container closure integrity. This webinar will review the new requirements and describe a practical road map enabling compliance:
- Implement a deterministic analytical method for container closure integrity testing.
- Such a method enables generation of robust science-based packaging data as required by the new Annex 1.
- Design packaging studies which a) demonstrate the achievement and maintenance of good container closure, and b) enable the design of an appropriate testing strategy.
Key Learning Objectives
- Learn how to interpret the new container closure requirements in the new EU GMP Annex 1.
- Understand how to develop deterministic analytical methods for container closure integrity testing.
- Understanding how to design packaging studies that generate robust science-based data demonstrating good container closure integrity.