I think that the intention of this part of Section 18 is that instead of creating another cell bank, or
another working cell bank was to say, okay, take a look at the performance of the cell bank that
you are currently using in production. So periodically take a look at it, and that could be just the
end of production cells that you’re running as part of your normal production and say do an
assessment. You need to ask yourself I’ve stored this cell bank for X number of years, this vial 87
of 225, is it still performing adequately? Certainly you should be taking a look periodically to make
sure that the cell growth characteristics and the quality of product are still being maintained.
For biotech products, if you’re in reasonably frequent or constant production, there’s no need to
make additional checks, just the normal controls and checks that are part of manufacturing are
adequate, but if you’re in an infrequent manufacturing situation, ICH Q5D actually gives some
specific guidance. I think it’s if you’re making less than one batch every two years, every two
years, you’re supposed to check the viability of the working cell bank. That’s my recollection of
the guidance. I don’t think though that that was intended to apply to conventional microbial
products but just to biotech.
