Objectionable Microorganisms: Keeping Bad Bugs Out of Good Products

No pharmaceutical company wants to sell a non-sterile drug contaminated with objectionable microorganisms, but how does a
company know which organisms are objectionable and how do they ensure their drugs do not contain them?

An objectionable organism is one which can either cause illness or degrade the product thus making it less eff ective. The U.S. Food and Drug Administration (FDA) states, “Appropriate written procedures designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established.” (21 CFR 211.113(b)) FDA continues, “There shall be appropriate laboratory testing, as necessary, on each batch of drug required to be free of objectionable organisms.” (21 CFR 211.165(b))

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