Hi, I’m Clive Mullins, currently the chair of ISPE’s Facility of the Year committee. I really welcome this opportunity to take a few minutes of your valuable time to give you an update on the 2009 Facility of the Year program.
The Facility of the Year Awards (FOYA) Program annually recognizes state-of-the-art pharmaceutical manufacturing projects utilizing innovative, new technologies both to improve product quality and reduce the cost of producing medicines.
FOYA recognizes the commitment of companies worldwide to innovate and advance pharmaceutical manufacturing technology.
It aims to disemminate these innovations to the wider community.
FOYA Success The Facility of the Year Awards program is a truly global event with more than 20 countries represented in previous years. Winners have hailed from Belgium, Canada, China, Denmark, Germany, Ireland, Japan, North America, and the UK.
Broad Scope It is not about size or good looks – it’s about innovation ; in 2006, a $5 million project received a FOYA Special Merit award.
cGMP manufacturing-based projects with majority of funding and effort devoted to buildings, equipment systems, and manufacturing methodologies deployed to manufacture regulated pharmaceutical drug substances, drug products, and other commercial entities under the purview of global regulatory bodies.
Project Execution: F. Hoffmann-La Roche, Penzburg, Germany
Facility Integration Flexibility across a broad variety of processes and batch sizes can be achieved, in a single facility, through creative use of building layout and zoning concepts. Multiple buildings are not necessary. B öehringer Ingelheim
Equipment Innovation Early- and late-stage clinical manufacturing and clinical scale-up can be delivered from the same facility Bristol-Myers Squibb
Operational Excellence Traditional and current vaccine technology can co-exist in the same facility IDT Biologika
Process Innovation Pfizer A facility can be designed to achieve a Design Exposure Limit that does not require the use of PPE.
Project Execution F. Hoffmann-La Roche Through excellent planning and execution, all three drivers …cost, schedule, and quality, can be met.
Congratulations to all of these outstanding project teams - the owners, service providers, vendors, suppliers, and contractors - for pushing the envelope in facility design and construction…and for giving the industry great lessons from which to learn.