Upgrade to Compliance. Keep Production Running.
GMP standards evolve. Facilities age. Shutdowns cost more than any upgrade.
Our experts begin with a technical and economic feasibility assessment to evaluate the remediation potential of existing facilities, utilities, and processes. Based on multiple scenarios, we select and implement the most viable approach to align operations with current EU GMP, FDA, and Annex 1 requirements while minimizing production disruption.
At GONVERT, we engineer practical, risk-based solutions that maximize the use of existing assets and infrastructure. Our strategy is to resolve critical deficiencies with minimal equipment replacement and facility downtime.
Through phased execution, containment strategies, and close coordination with QA and Operations, we implement upgrades during planned shutdowns and maintenance windows. For legacy systems, we apply a science- and risk-based qualification approach to close gaps efficiently.
The result: a compliant, inspection-ready facility that leverages what you already have, avoids unnecessary capital spend, and stays in operation.
Key Areas of GMP Upgrade & Remediation Expertise:
- Feasibility & Scenario Analysis – technical and economic evaluation of upgrade options
- Regulatory Gap Analysis – EU GMP Annex 1, FDA, Data Integrity, and industry best practices
- Risk-Based Remediation Planning – prioritize critical GMP deficiencies relative to business impact
- Asset Maximization Strategy – upgrade and retrofit existing equipment before replacement
- Phased Execution & Containment – minimize downtime through planned shutdowns
- Facility, Cleanroom & HVAC Upgrades – targeted improvements to enhance compliance and performance
- Utility & System Qualification Recovery – remediate historical gaps with lean documentation
- Inspection Readiness & Sustainability – prepare for audits and maintain long-term compliance
