When we talk about objectionable organisms, we’re really thinking of the intended use of the
product and what organisms would be objectionable based upon that intended use. One example
is a topical ointment that is placed over an open wound. If you had Pseudomonas contamination
in that ointment, that would be objectionable. So, objectionable really ties into the intended use of
the drug product and whether it the presence of that organism would be objectionable given that
intended use. USP identifies indicator organisms, pathogens that should be tested for under
certain circumstances.
