Pharmaceutical Equipment Requalification Case Study

How Rephine helped a leading pharma client implement a scalable, risk-based requalification strategy

Faced with the challenge of managing complex equipment requalification across multiple global manufacturing sites, a major pharmaceutical client turned to Rephine for expert support. The client lacked internal capacity and policy direction to meet GxP and Annex 15 requirements — especially across facilities with varying layouts, products, and equipment types.

Rephine’s consultants stepped in with a structured, risk-based approach, developing requalification policies, protocols, and assessment tools tailored to site-specific realities. Starting with two critical manufacturing plants in Spain, the strategy was designed to scale globally.

Download the full case study to discover how Rephine helped the client:

• Identify and prioritise high-risk equipment through site-specific risk assessments
• Establish standardised requalification protocols and documentation
• Streamline qualification efforts and reduce time spent on low-risk assets
• Achieve greater compliance confidence and faster rollout across international sites

Result: A compliant, scalable, and efficient requalification process that supports long-term operational control and audit readiness across all locations.