SCOPE OF WORK
To manage a revamping project: shift from a 5mL vial primary packaging to 5L plastic bottles
Aseptic environment
GMP
INVOICING & DURATION
• Duration: 10 months
• Hourly rate
OUTCOMES
• URS writing (equipment – primary packaging, tanks) and utilities – waterloop, HVAC, electricity)
• Selection of suppliers
• Works monitoring
• CQV works from FAT to PQ
• Change control