The draft guidance document is ambiguous and leaves
the decsion to the stability study administrators. The
reason for this is that ascientific judgement has to
be made as to whether the degradation products are
likely to have an effect on the analytical method.
For LAL testing I advise that the
inhibition/enhancement profile be determined for
stabilty study lots if available to account for this
Remember that the registered LAL procedure should be
valid throughout the life of the product so it would
be prudent to include this requirement in the
stability study protocol.
I hope that this helps but should you require any
further information please don't hesitate to get in
--- Mark E Claerbout <[log in to unmask]>
> Dear forum members,
> I am interested in getting opinions as to the need
> to perform LAL testing on
> dry sterile dosage forms on stability, and whether
> of not companies are
> routinely doing this. The 1998 FDA draft guidance
> document on Stability
> Testing of Drug Substances and Drug Products
> indicates it "may" not be
> necessary (page 38 of the document), which seems
> rather ambiguous to me.
> thanks in advance for any responses,
> Mark Claerbout
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