Facility Audit

Facility Audit

Ensuring Compliance, Efficiency, and Operational Excellence

Agon ME provides comprehensive Facility Audit services to help pharmaceutical and medical manufacturing sites meet GMP and international regulatory standards, including JFDA, SFDA, USFDA, EMA, and GCC. Our experts conduct detailed on-site evaluations covering facility design, equipment qualification, documentation systems, and production workflows — ensuring every element supports compliance and efficiency.

What We Deliver

Comprehensive On-Site Assessment

Evaluation of facility layout, HVAC, utilities, and production areas
Review of equipment qualification and calibration systems
Verification of documentation and operational controls

Gap Identification & CAPA Planning

Audit preparation aligned with GMP and international authority requirements
Support for inspection readiness and certification processes
Guidance for maintaining compliance during scale-up or expansion

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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