211.166(5)b says, “Accelerated studies combined with basic stability information on the
components, drug products, and container closure system, may be used to support tentative
expiration date, provided full shelf-life studies are not available and are being conducted. Where
data from accelerated studies are used to project a tentative expiration date that is beyond a date
supported by actual shelf-life studies, there must be stability studies conducted, including drug
product testing at appropriate intervals, until the tentative expiration is verified or the appropriate
expiration date determined”.
Again, that is talking about expiry dating. The question related to retests, and the question again,
the person talking about retest was not saying this would be the only data, and they would not
have any real shelf-life data. This would be in addition to, and help them justify.
Q7A tried to address specifically the Good Manufacturing Practices. Typically, the stability
development studies are a function of the filing requirements, which are addressed in Q1, which
does talk specifically about how stability development is done. Since Q7A is a Good
Manufacturing Practice document, it is saying you’ve already done the things you need to do for
filing, and this is what you would do on an ongoing basis. So, the stability that’s addressed in the
laboratory section of Q7A needs to be the ongoing after filing.
Your stability program could be dealt with in your filings up front. In other words, if you’ve got a
commercial product that you’ve filed for, you could get agreement from the reviewing branch up
front to a special approach to a stability program, and that should become then a moot point from
a GMP perspective. That’s your option that you can work on developing.
