Microbial contamination continues to be the leading cause of recalls of drug and cosmetic products, so, understandably, the first reaction to microbial recovery may be one of dread. However, as with most things in life, understanding what to do, and having a thorough plan, can alleviate at least some of the worries. Most people know that in addition to quarantining potentially affected lots, a thorough investigation needs to be conducted to assess risk. Part of this risk assessment needs to include the characterization of the organism(s) recovered – this is where many run into trouble. While occasionally the recovery may be one of the “named” objectionable organisms from USP, most of the time, the organism is identified to be something else. Should these organisms be considered objectionable? An Organism Risk Assessment (ORA) needs to be conducted to find out. While the specifics of an ORA can vary between industries, and be influenced by the specifics of the situation.
An ORA will virtually always consist of several key pieces:
Ideally, an ORA would be conducted by a qualified microbiologist. Minimally, the person conducting the risk assessment should have significant microbiology training so that they are competent not only to interpret the wide array of literature that will be evaluated throughout the assessment process but also in how to apply that information to the specifics of the individual contamination event. It is also crucial to understand that regardless of what information is uncovered during the ORA process, a full risk assessment/OOS investigation is required. Not all companies have this expertise in-house. Q Labs Consulting has decades of experience in performing a variety of microbial risk assessments including ORAS, and we are happy to lend our team of experts to help! Visit us online to learn more!