GMP and FDA Equipment Qualification
Our equipment qualification process ensures FDA and GMP compliance, helping pharmaceutical and biotech companies meet critical regulatory standards. At SOKOL GxP Services, we design and execute IQ, OQ, and PQ protocols as part of our broader CQV services, ensuring your systems are validated and audit-ready.
Comprehensive Equipment Qualification
Full lifecycle coverage, from initial risk assessments through final validation. We ensure equipment consistently meets FDA and GMP requirements by applying a structured CQV approach.
Detailed Documentation and Compliance Support
We provide tailored qualification protocols (IQ, OQ, PQ) and comprehensive reports that withstand regulatory review. Our documentation is designed for seamless integration into your quality management system and supports FDA submissions and audit readiness.
Qualification Project Planning and Execution
Our team manages each phase of the equipment qualification project, from planning and scheduling through execution. This ensures operational readiness, compliance, and minimal disruption to ongoing manufacturing activities.
1. Planning & Alignment
We align on qualification strategy, timelines, and regulatory expectations, working within your SOPs or developing new GMP-compliant protocols.
2. Commissioning
Equipment installation and functionality are confirmed as the foundation for qualification.
3. Risk Assessment
Equipment complexity and impact on product quality are assessed to define scope and testing needs.
4. Qualification (IQ/OQ/PQ)
Protocols are executed to verify equipment capabilities, controls, and performance consistency.
Our Process
FAQS
- 01
- 02
- 03
