Are Medical Device Makers Ready for USP Section 1079 Revisions?

Pharmaceutical Commerce reported this month that cold-shipping and storage requirements are slated to change due to revisions of section 1079 of the USP guidance. Which of the changes/recommendations below do you think will affect medical manufacturers most in 2010?

• Labeling instructions
• Temperature monitors
• Refrigerated or insulated packages
• Overall quality management system (QMS)
• Comprising a storage management system (SMS)
  Comprising a transportation management system (TMS)
• Comprising an environmental management system (EMS)
• Recommendations for a risk management system