• Risk analysis
• Definition of a qualification strategy (DQ, IQ, OQ, PQ)
• Design of qualification documentation : master plan, protocols, tests specifications, reports
• Tests execution, including air flows control, and differential air pressures controls.
• Training
• Audit of your facilities qualifications.

Get QUALILAB’s help when designing your new plant

• User requirement specifications
• Review of blueprints and specific plans (flows, pressure gradients, air flow station)
• Design or audit of your application file for opening or modifying your pharmaceutical facilites (according to the French Agency AFSSAPS requirements)