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
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