Root Cause Analysis

GMP INSPECTIONS

Internal GMP inspections identify minor and potentially significant issues or opportunities that may lead to timely and permanent corrective actions. Audits focus on thorough review and documentation. Root cause analysis is comprehensive and targets prevention

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ROOT CAUSE ANALYSIS

Where areas are positive (presumptive or confirmed), root cause investigations, mitigation and/or corrective action strategies are deployed. Possible mitigation strategies include re-routing traffic, employment of GMPs, and/or sanitation. In addition, employees are trained to spot

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CORRECTIVE ACTIONS

Positives are followed up with immediate retesting to prove consecutive negatives (minimum 3). Source identification (vectoring) is applied source is eliminated. Learnings are applied in operations as appropriate.

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meyoung@affi.com
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