Pharmaceutical Equipment Requalification Case Study

Requalification isn’t just about ticking boxes—it’s about building control and confidence into every site, system, and schedule. Our role is to bring structure, strategy, and simplicity to even the most complex GxP environments.

~Rephine Qualification Lead Consultant

About this 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.