We tried to address that in the presentation. The ICH guideline you are referring to is directed at
the dosage form manufacturer. If you look back at the slides, we talked about assigning retest
dates by the API manufacturer, and talked about assigning additional retest dates by the dosage
form manufacturer.
The EWG was didn’t know what was motivating that segment of people that are pushing for
testing of an API immediately before use. If you’ve got stability data that allows you to keep this
material in use, and it’s good for a year, to require a dosage form manufacturer, while it’s within
that year period, to test it the day before they use it is unrealistic and impractical. It’s not a sound
scientific argument.
ICH tells us that, wherever possible, definitions should be the same between different guidance
documents so that there is not confusion. But, in some cases in Q7A, there truly were unique
situations, where the expert working group felt that there was justification for having a different
definition. The EWG discussed at length the fact that it does not conform to the other definitions,
because it does not include the phrase requiring that it be used immediately. However, the EWG
felt that the difference was justified and necessary.
