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July 2020


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Devendra Badgujar <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Thu, 9 Jul 2020 10:15:05 +0000
text/plain (39 lines)
Dear Forum members,

As per the USP <1111> the microbiological quality requirement for the drug substances (API) is only TAMC & TYMC,  there is no any requirement mention for specified microorganisms.
I have question, it is required to perform the test for specified microorganism for drug substance (API) which are use either in non-sterile formulation and sterile drug preparation?
I want to  know across industry practice.  Any ref. for specified microorganism for drug substance?

Thank's  & Regard's
Devendra Badgujar

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