Reply To: Time Out of Storage / Refrigeration

[Neil Armstrong]

Reply To: Time Out of Storage / Refrigeration

You are certainly justified in seeking clarification on this matter, as understanding the tolerance for time spent outside of specified conditions is crucial information to provide to your chosen IMP packager. It may be beneficial to seek a temperature excursion risk analysis or a summary of the long-term stability/thermal cycling report from your QA.

You mention the company is running multiple late-stage trials, it is possible that thermal cycling assessments addressed a cumulative impact from multiple excursion events as a non-issue, placing emphasis solely on limiting individual excursions.