The cosmetic products industry has a history of recall notices that name the following organisms as microbial contaminants: B. cepacia, P. aeruginosa, S. aureus, K. pneumonieae, and S. marcescens. The presence of these opportunistic microorganisms in products is hazardous to consumer health and has severe consequences. Aside from consumer safety, microbial contamination is also costly in financial impact and longer-term damage to the brand’s reputation. So how can you reduce the risk of a product recall associated with harmful microorganisms?
The first step in most risk-reduction approaches is identification of the organism. Accurate identification can only occur with robust methods and the organism presence in the microbial library. For maximal regulatory compliance, the standards and principles applied to cosmetic products can be based on those in the non-sterile pharmaceutical industry. In addition to industry-known objectionable organisms, the significance of any microorganism that is recovered from microbial testing should be evaluated to determine whether it is objectionable (USP <1111>) for each specific product. Similarly, the Parenteral Drug Association, in Technical Report No. 67, recommends a systematic framework to structure available data and knowledge into a cohesive and transparent tool to enable decision-making and inform risk management. In other words, regulators recommend routine environmental monitoring, a fundamental aspect of cGMP compliance, and data trending as a best practice.
It is well recognised that final product testing of a production batch is not a complete picture of whether the entire batch is contamination-free. Thus, environmental monitoring (EM) is just one way to reduce risk by detecting possible contamination throughout the manufacturing process. Evaluating the effectiveness and integrity of your EM program on a routine basis is essential, as well as trending your EM data to look for areas that can be better controlled. This results in better compliance, increased quality, and consumer safety.