Regulatory Guidance on the Life Cycle Approach to Container Closure Integrity Testing

Synopsis

This presentation will look at the path of regulatory guidance over the last decade, in the context of container closure integrity inspection for pharmaceutical product packaging and help explain what this means across the manufacturing life-cycle.
We will cover why different approaches and justifications need to be considered for different stages of product development and manufacture and look at emerging technologies and where they fit across these various stages.

– Overview of regulatory guidance for CCIT
– interpretation of the guidance
– understanding the approach to choosing and justifying which method to apply to your product
– Overview of new technologies