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May 2018

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Subject:
From:
"Voigt, Thomas" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 29 May 2018 15:00:22 +0000
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Good Morning,

For a product formulation, they want to remove one of the excipients (Boric Acid).  It will be the same API concentration and all of the other excipients, just minus the boric acid.  Would you have to repeat micro validation testing (B/F, E/I, and bioburden qualification)?   Would you consider the formulation with the boric acid as almost a worst case?  Sorry I am used to seeing something being added to the formulation not removed.

Thanks,
Thomas


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