- 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
