A tightly closed container is a prerequisite for aseptically filled parenteral drug products to be safe. Therefore, regulatory authorities expect demonstration that Container closure integrity (CCI) is maintained throughout product shelf life. Good practice recommends to build CCI into the development, industrialization, lifecycle management and quality management processes, as opposed to solely testing manufactured items. Starting with an overview of the regulatory framework and expectations, the webinar showcases the practical activities occurring from the early stages to the product launch and beyond.
How can you ensure a tightly closed container for aseptically filled biologics drug products?
In this webinar you will be walked through:
- A comprehensive approach to CCI tailored for several biologic drug products -mAbs and complex modalities such as fusion proteins or bioconjugates
- Regulatory expectations and industry best practices on CCI
- Timely activities initiation of more complex cases such as combinations products