Congratulating the project team, Alan MacNeice, Jazz Pharmaceuticals’ Ireland Executive Director and Site Leader said “Your efforts have been recognized for project execution excellence, placing you among the best in the global pharmaceutical industry last year”.
This was Jazz Pharmaceuticals’ first internal manufacturing facility and the ISPE judges were impressed by the project execution approach which was highly pragmatic, and a model for lean project execution and integration of the investment from “project” phase to licensed GMP operations.
Over two years, the small Jazz Pharmaceuticals’ team established from nothing, a fully integrated controlled drug manufacturing and development facility with a full range of quality and management systems. The timeline was all the more impressive as it included three months of validation batch stability studies before the PAS was submitted to US FDA.
Alistair Finlayson, Project Manager, PM Group added “I’m delighted that Jazz Pharmaceuticals has been acknowledged with this prestigious award. The project’s success recognises the commitment and unity of purpose of the project participants and fast and effective decision making by a small and empowered client team”.
Now licensed by the US FDA and Irish HPRA to manufacture Xyrem®, a treatment for narcolepsy, This greenfield facility incorporates a cleanroom manufacturing suite, warehouse with a controlled drug vault, quality control laboratory, offices, supporting utilities and shell space to facilitate future development.
The ISPE’s Facility of the Year Awards is the premier global awards programme recognizing innovation and creativity in the manufacturing facilities serving the regulated healthcare industries. As a category winner the Jazz facility is now shortlisted, with seven others, for the overall award to be announced later this year.
Key Project Participants:
- Engineer/Architect: PM Group
- Construction Manager: PM Group
- CQV: CAI
- Civil Works: Wills Bros
- Building Contractor: John Sisk & Sons
- Cleanrooms: Ardmac
- Piping/HVAC: Leo Lynch
- Electrical: Suir Engineering
- Automation and Control Supplier: Rockwell Automation
- Major Equipment Suppliers/Contractors: Marchesini Group; Kells Stainless (ABEC Technologies Europe Limited)
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