Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing

The adoption of rapid sterility testing has significant benefits to the pharmaceutical industry; providing early notification of control drifts, a non-subjective answer to the sterility test and a faster time to product release. However the challenges of adoption can be daunting.

By enhancing the benefits of regulatory interactions in the development phases, a complex post-approval regulatory change can be mitigated, however with limited material available, the outlined strategy provides a robust way forward to adopt rapid sterility and capture the benefits.