Beacon Pharmaceuticals Ltd. is designed to achieve full compliance with the most stringent worldwide regulatory requirements of the following agencies, both from design and operation basis:

• EU GMP (2002 Edition)
  
• CGMP (21 CFR part 200 and -299)
  
• USP 25 and European Pharmacopoeia 4th Edition: Purified water and WFI.
• ISPE Guidelines (Volume 2, 3 and 4)
  
• Classification of the air's cleaning according to European GMP attached 1 and the ISO 14644
  
• European basic building normative NVE (European norms)
  
• DIN and ASTM normative for piping flowing of pressurized fluids.
  
• ASHRE normative for the HVAC system.
  
• A-D-Markblatter, British standard BS 2646 or ASME code normative for the design of the materials strength in reactors, ovens and autoclaves.
  
• MIBI 0-25 for electric design.