Conduct a root cause analysis to identify any potential sources of contamination or factors that may have contributed to the exceeded limit.
Notify QA and production teams immediately.
Conduct laboratory and analyst investigations to determine potential causes.
Inspect the production area, checking differential pressure, temperature, personnel movement, and any ongoing engineering work.
In the laboratory investigation, examine negative control plates, pre-incubation conditions, possible analyst errors, proper training, and details of media preparation.
Perform additional environmental monitoring to verify whether the alert level was an isolated event or part of a trend.
Ensure that the cleaning and disinfection protocols are being followed properly and evaluate if adjustments are needed.
Assess if any products or processes were potentially affected by the contamination and take necessary actions, such as quarantining or re-testing the product.
Based on the findings, implement corrective and preventive actions (CAPA) to prevent
