The Facility of the Year Awards (FOYA) Program annually recognizes state-of-the-art pharmaceutical manufacturing projects that utilize innovative technologies to improve product quality and reduce production costs. FOYA aims to disseminate these innovations to the wider community. Winners have come from over 20 countries and represent projects of all sizes, with a $5 million project receiving an award in 2006. Eligible projects involve new or renovated cGMP facilities constructed between November 2006 and November 2008 that focus on innovation in areas like personnel safety, environmental impact, and energy management. Awards are given in categories like Process Innovation, Equipment Innovation, and Operational Excellence. The 2008 winners demonstrated innovations such as flexibility to produce multiple products in a single facility and co

1. Facility of the Year Awards Program 2009

2. What is it? 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.

3. Aim FOYA recognizes the commitment of companies worldwide to innovate and advance pharmaceutical manufacturing technology. It aims to disemminate these innovations to the wider community.

4. 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.

5. 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.

6. Eligibility 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.

7. 2009 Eligibility Any newly constructed free-standing facility, facility addition, or major interior renovation of an existing facility constructed between 1 November 2006 and 30 November 2008 is eligible.

8. Submission Criteria Essential Requirements: Personnel safety Construction safety Hazard control Environmental impact Energy management Access for people with disabilities (if applicable)

9. Submission Criteria Significant Contributions In: Project Uniqueness and Innovation Quality Operational Excellence Project Execution Sustainability

10. Awards Categories Awards are presented to winners in the following categories: Process Innovation Project Execution Equipment Innovation Facility Integration Sustainability Operational Excellence

11. 2008 Winners Facility Integration: Böehringer Ingelheim , Biberach, Germany Equipment Innovation: Bristol-Myers Squibb, New Brunswick, NJ, USA Operational Excellence: IDT Biologika, Dessau-Rosslau, Germany Process Innovation: Pfizer, Illertissen, Germany Project Execution: F. Hoffmann-La Roche, Penzburg, Germany

12. 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

13. Equipment Innovation Early- and late-stage clinical manufacturing and clinical scale-up can be delivered from the same facility Bristol-Myers Squibb

14. Operational Excellence Traditional and current vaccine technology can co-exist in the same facility IDT Biologika

15. Process Innovation Pfizer A facility can be designed to achieve a Design Exposure Limit that does not require the use of PPE.

16. Project Execution F. Hoffmann-La Roche Through excellent planning and execution, all three drivers …cost, schedule, and quality, can be met.

17. Excellence 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.

18. You can’t win it if you’re not in it! Participate Your new or renovated facility could be a Facility of the Year Award winner!

19. Intent to Submit Form Due 13 October Next Steps Visit facilityoftheyear.org to download your submission forms. Submissions Due 1 December

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