----- Forwarded by Fausto Silva/Pharmacare/za on 06/12/2002 12:08 -----

                    Fausto Silva
                                         To:     [log in to unmask]; [log in to unmask]
                    06/12/2002           cc:
                    12:03                Subject:     Question regarding PET test





Hi Roger, Tony

I am sure this question has come up before, but I never really got a
conclusive answer to put this matter where it belongs and it R.I.P. Amen!

It is regarding PET testing of oral reconstitutable powder antibiotic for
suspension and the persistence of our regulatory pharmacists requesting the
test.

My stand point:
If the label says use within 7 days at room temperature and then discard!
What is the use or even the scientific argument in testing it over 28 days?
There are no guidelines that I have seen for a log reduction within 7 days
in any of the pharmacopoeias! What do I do?
There was already a case where a product also in powder form was tested and
failed the yeast miserably, then everyone was "jumping" around until me and
my QA manager said the above, it just does not make sense to test it under
the circumstances!

What about injections also for reconstitution but for single dose use?
Should we just use the 6 hr data obtained in a the PET test for
parenterals, and the mutli-use dosage, I suppose that one should be tested
right?

Thanks in advance for your answers.

Fausto C. de Paula e Silva
Microbiology Section Head
Aspen-Pharmacare (Lennon site - Port Elizabeth)


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