GMP Compliance for API Manufacturing: Requalifying a Fire-Damaged Plant

One of the key suppliers was Rephine, which carried out the entire qualification cycle for all equipment and services. Their commitment and professionalism were key to overcoming this challenge and allowing us to continue our operations.
— Jordi Tugas Barrero, Chemical Plants Facility Management Director

About this Case Study

This case study explores how Rephine helped a multinational fine chemicals company restore GMP compliance for API manufacturing after a devastating fire. The incident damaged the majority of the site’s production equipment and infrastructure, requiring a full validation and requalification process.

To ensure regulatory compliance and minimise supply chain disruptions, Rephine:

Developed a Validation Master Plan (VMP) to guide the revamp
Assessed all legacy systems and new installations
Conducted targeted upgrades and risk assessments
Executed qualification protocols for equipment, utilities, and cleaning
Implemented a phased restart strategy aligned with product priorities

Through this GxP-led approach, the plant restarted within 11 months—well ahead of industry benchmarks—ensuring supply continuity and future scalability.

Download the full case study now and discover how Rephine enabled GMP compliance for API manufacturing through expert-led validation and qualification activities—ensuring rapid recovery and long-term operational success.