Bringing Existing Facilities Back to Compliance and Performance

At Gonvert, we deliver GMP Upgrade and Remediation programs that close compliance gaps while protecting production, business continuity, and future operational performance.

We begin with a comprehensive GMP Gap Assessment aligned with current FDA, EMA, WHO, and applicable regulatory expectations. Working closely with your QA, Production, Engineering, and Technical SMEs, we identify and prioritize the deficiencies with the greatest impact on product quality, patient safety, data integrity, and compliance.

Using a risk-based approach, we develop a practical Remediation Master Plan with a clear scope, schedule, budget, and implementation strategy. Our EPCm team then manages engineering modifications, facility upgrades, utility improvements, equipment remediation, and qualification activities through a structured change control process.

For each improvement, we provide supporting documentation, including URS, Risk Assessments, Design Reviews, IQ/OQ/PQ, and updated procedures, ensuring complete traceability and compliance readiness. The result is a facility that operates more reliably, meets current GMP expectations, supports future inspections, and extends asset life without unnecessary capital investment.

As your EPCm partner, we manage the complexity of remediation so your team can remain focused on manufacturing, product quality, and business growth.

Key GMP Upgrade & Remediation Services You Will Benefit From at Gonvert:

  • GMP Gap Assessments — identifying compliance and operational deficiencies
  • Remediation Master Planning — prioritizing actions based on risk and business impact
  • Facility & Process Audits — evaluating compliance against current GMP expectations
  • SME-Led Risk Assessments — focusing effort on critical quality and compliance risks
  • Facility & Cleanroom Upgrades — improving performance and regulatory compliance
  • HVAC & Utility Remediation — strengthening reliability and contamination control
  • Equipment Upgrade Programs — extending asset life and operational capability
  • Documentation Remediation — restoring traceability and compliance records
  • Qualification & Validation Recovery — resolving historical CQV deficiencies
  • Change Control Management — maintaining compliance during implementation
  • Data Integrity Improvements — strengthening regulatory confidence
  • Operational Continuity Planning — minimizing disruption to manufacturing
  • Inspection Readiness Support — preparing for regulatory audits and inspections
  • Lifecycle Asset Improvement — maximizing long-term facility value