Out of trend (OOT) and out of specification (OOS) results for Microbiology testing are inevitable challenges that every sterile manufacturing environment must face. These results can arise from a range of sources, including environmental monitoring data that is recovered from sterile environments, or from testing of the product at either the in-process or final stages of production. A critical part of managing OOT and OOS results is performing proper investigations of the failing results; however, a universal challenge when performing investigations is the delay in obtaining results due to incubation times. This challenge can be mitigated by having the proper controls in place for testing and sampling the environment before OOT and OOS results occur.
Additionally, in order to conduct a thorough investigation and understand changes in variables that could impact the quality of the results, it is important to properly interpret historical trending data and relate it to variables such as changes in personnel, equipment, raw materials, differences between shifts, and even time of year. While this information, in addition to retesting, can be used to determine possible root causes for the results, it is important to understand the limitations of the data. On their own, microbiology testing results are just a snapshot in time or a certain percent of the product yield. These subjects along with guidance on how to approach them will be explored to aid with conducting investigations and making risk assessments.
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