Commissioning and Qualification Services for Facilities
We provide commissioning and qualification services for pharmaceutical facilities and critical utilities validation. From HVAC and cleanrooms to water systems and gases, SOKOL GxP Services ensures your infrastructure meets the highest GMP compliance standards.
End-to-End Qualification and Commissioning
We deliver commissioning and qualification support across the facility lifecycle, from early assessments to IQ/OQ/PQ execution. Our approach ensures systems are fully functional, compliant, and ready for regulatory inspection.
Critical Utility Validation
HVAC, purified water, clean steam, and process gases are qualified to confirm performance and reliability under GMP conditions. Our protocols focus on ensuring consistent utility performance that directly supports product quality.
Customized Documentation and Audit Support
Each project is supported with tailored protocols, validation master plans, and final reports. Documentation is structured for integration into your QMS and is prepared to withstand FDA, EMA, and global GMP audits.
1. Planning & Alignment
We align with your team on project scope, timelines, and regulatory expectations, adapting to your SOPs or creating new GMP-compliant protocols.
2. Commissioning
Facilities, utilities, and equipment are verified as installed and functioning correctly, forming the baseline for qualification.
3. Risk Assessment
System and utility risks are evaluated to define qualification scope and the right level of testing.
4. Qualification (IQ/OQ/PQ)
Protocols are developed and executed to confirm HVAC, water, gases, and other critical systems meet GMP standards.
Our Process
FAQS
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