Integrated CQV and Validation Strategy for a Global Plasma Manufacturing Site

Case Study

The Client's Challange:

To meet rising plasma product demand, a leading biopharmaceutical company partnered with an engineering and construction firm to design and build a massive plasma fractionation facility—the largest in the world. It soon became evident that internal resources were insufficient to manage the complexity of project delivery. CORE was awarded a contract to provide CQV (Commissioning, Qualification, and Validation) and Owner’s representation.

Our Solution:

CORE restructured the validation model into a project-based execution system:

• Developed a “test once, document once, approve once” strategy, minimizing redundancy and maximizing speed to market.

• Coordinated with regulatory affairs to prepare validation summary reports suitable for direct regulatory submission.

Halfway through the project, the client was acquired by a global biopharmaceutical company, which continued to work with CORE because:

• CORE had become essential to project planning, management, and delivery.

• CORE adapted quickly to the new self-performing model and continued to lead final validation and regulatory submission efforts.

The Results:

• Final inspection conducted by the German authority, with FDA observing.

• FDA waived their own inspection.

• Submission finalized the day after validation wrapped, shaving 3–4 months off the timeline.

• The facility was awarded ISPE Facility of the Year (2014).