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Objectionable Organisms

There is a great deal of interest in the topic of "Objectionable Organisms" in the regulated industries.  A central question in this topic is "how do you determine if an organism in your product is objectionable?"  This has been a source of concern for years in the pharmaceutical and OTC sectors.  Now it is becoming a source of concern for cosmetics manufacturers, personal care products and even compounding pharmacies.    The Microbiology Network has several national experts in non-sterile Quality Control (QC) microbiology.

The pharmaceutical GMP (21 CFR 211) mention objectionable organisms in three passages:

  • 21 CFR 211.84(d)(6) "Each lot of a component, drug product container, or closure with potential for microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use."
  • 21 CFR 211.113(a)  "Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed."
  • 21 CFR 211.165(b) "There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms."

So, from this we can determine that incoming raw materials and packaging must be determined to be free of objectionable organisms, that SOPs must be in place "designed to prevent objectionable microorganisms in drug products not required to be sterile" and that non-sterile finished product must be shown free of objectionable organisms.

Note that no requirement in the GMP mentions the USP Microbial Limits Tests (USP <61> and USP <62>) as suitable tests for objectionable organisms.  Do not make this mistake!

Let the expert consultants at Microbiology Network guide you through the necessary risk analysis to determine the safety of your non-sterile product, or to answer FDA concerns expressed in 483 or warning letters about the microbiological safety of your products.