Objectionable Microorganisms/Pathogen Specific Assessments

The topic of objectionable organisms is often deliberated, but defining what is objectionable is a challenge; primarily as QC microbiologists are rarely privy to patient information such as population, or the immune health. It is critical to have adequate background knowledge to determine the clinical implications of the organisms being assessed for patient risk.

Identifying objectionable organisms is a requirement per the three separate citations in the current GMPs.

  1. 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.”
  2. 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.”
  3. 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.”

Objectionable organisms are pathogens – and not all pathogens infect in a consistent manner. Additionally there are true pathogens as well as opportunistic pathogens; a true pathogen is an infectious agent that causes disease in virtually any susceptible host. Opportunistic pathogens are potentially infectious agents that rarely cause disease in individuals with healthy immune systems. To understand the potential patient specific risk of an organism there are various factors to be considered.

Microrite’s team of clinical microbiologists and mycologists help identify objectionable microorganisms and perform pathogen specific assessments in relation to pathogenicity, infectivity, virulence and patient safety. They also evaluate emergence and re-emergence of specific pathogens.
Pathogen specific risk assessment performed by Microrite’s team greatly help quality and regulatory departments make informed decision about product batch disposition.