Container–closure integrity (CCI) is a vital patient-safety and product-efficacy aspect of parenteral biopharmaceuticals. The challenge is how to identify, qualify and maintain the appropriate methods to ensure CCI’s role in providing patient and regulatory confidence in these medicines.
To describe an overarching approach to CCI and BioPhorum’s work in this area, Scott Ewan has written an article called A Holistic Approach to Container–Closure Integrity – An Industry-Wide Collaboration.
He discusses how BioPhorum’s approach brings together all the pieces of the CCI puzzle and is structured around a standardized product lifecycle. The approach is divided into five stages of that lifecycle:
- Container–closure system development
- Container–closure system qualification
- Container–closure system validation
- Routine manufacturing
- Stability and shipping.
Through this structure, the BioPhorum team will illustrate how confidence in integrity assurance can be demonstrated through means other than CCI testing. This will be published on www.biophorum.com in the fourth quarter of 2020.
As well as the holistic approach, Ewan discusses sampling, user requirements and BioPhorum’s technology roadmap, and the appendices to the approach. He also talks about how taking a holistic approach to CCI requires building quality into biopharmaceutical products and processes — rather than blindly testing without adding value to products or for patients.
The assurance of CCI can often be demonstrated most effectively by other means established through development and quality risk management activities. However, whenever a risk assessment indicates that CCI testing is mandated, the team’s paper will facilitate the effective testing of valid sample sizes using appropriate and relevant methods.
The article is contained in a new e-book from BioProcess International, called Formulation, Fill, Finish Biopharmaceutical Drug Products for a Modern Age, which highlights formulation concerns and collaborative efforts toward solving a fill-finish conundrum.