Corrective Actions

FOOTBATHS AND ENTRY AREAS

Foot and wheel hurdles should be established and maintained at entry points and between hygienic zones. Dry powder sanitizer should be used in dry areas and dry/wet transition zones. Foot bath/foamer concentrations, when used, and

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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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GMP AUDITING

Internal audits are in place and performed at a regular frequency. Corrective actions are implemented & documented. Learnings are shared and effectively communicated across the company with all relevant personnel.

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VECTOR SAMPLING METHODS

Corrective actions are taken to eliminate the cause of an environmental positive are not only effective, appropriate and documented, but also shared with EM cross-funcational team and applied as appropriate. Positives are followed up with

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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
443-904-3937

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