GXP

Objectionable Organisms

Abstract

The topic of “objectionable organisms” is frequently found in regulatory observations and publications.  While there is a good understanding that companies need to know the objectionable organisms, there is not much guidance on which organisms should be on this list, as there are many factors that are company specific in determining the affected microorganisms.   This article discusses the need for procedures regarding objectionable organisms as well as methods to determine the organisms that should be on this listing.

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