Matthias Schaar, Technical Steward Microbiology, Novartis Pharma
Container Closure Integrity in pharmaceutical sterile production is a requirement to maintain sterility of the drug product. After the USP chapter had a major update in 2017 with regard to testing methods and testing recommendations the new Draft of Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide also implemented a more detailed discussion about Container Closure integrity testing. The first revised version published in 2017 resulted in discussions about testing strategies which leaded to a new revised version published in February 2020.
This Webinar is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
- Quality Assurance and Quality Control
- Inspection and Auditing
or who are involved in
- Sterile/Aseptic Manufacturing
- Contamination Control and Monitoring
- Process Simulation/Media Fill
This webinar will give you a short overview about Container Closure requirements and method discussions and focuses the planned implementations in Annex 1 considering both drafts with regard to Container Closure Integrity Test.
Duration of the Recording: Appr.1,5 h
Recording from 28 August 2020