GMP and FDA Equipment Qualification
We support the full equipment qualification lifecycle including protocol development, execution, deviation management, and final report generation for QA approval. Our team performs IQ, OQ, and PQ in accordance with GMP and FDA expectations.
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
Why Partner with SOKOL GxP Services?
Deep understanding of GMP validation frameworks
Structured protocol development
Technical teams with engineering background
Transparent communication throughout project lifecycle
Our Process
1. Planning & Alignment
We align on qualification strategy, timelines, and regulatory expectations, working within your SOPs or developing new GMP-compliant protocols.
