Always a great conundrum for Stabilitarians. The question first came up with European inspectors more than 15 years back. They wondered how we would deal with the impact of multiple excursions. It was just a question, not a finding, but we’ve been wrestling with it ever since. I’ve learned that using the Iso-conversion process on a product well characterized by Iso-conversion ahead of time makes it possible to make such a calculation. Relatively few of us have products that have followed that path, but I think that Auditors are mostly satisfied if we have a written plan to deal with multiple excursion situations.Justification is the key to legitamize what ever method we choose. Stability budgets and accelerated data are often the basis for such plans.
John O’Neill
