Theoretically, yes. When you make a change, the difficulty is to show that it has no impact on the
quality, especially on those parameters that you normally do not measure, like physical and
chemical parameters. From this point you have to do some studies anyway.
There’s also a non-Q7A issue, i.e. does that change affect your regulatory filing? You may have a
change that doesn’t affect the quality of the product, but it may affect the registration filing.
