Guest speaker at the 1st International Conference of the Jordan FDA

At the first international conference of the Jordan Food and Drug Administration, Dr. Aziz Chraibi gave a 60-minute presentation on cGMP design requirements for sterile injectable facilities.

Title: “Updated cGMP Aseptic Design Requirements of Sterile Injectable Facilities: FDA, EMA, HC, GCC.” The talk covered cGMP regulatory expectations, industry trends and design best practices for sterile and aseptic manufacturing facilities: layout, sanitary equipment, utilities, pharmaceutical systems and quality system requirements.

On the program

• cGMP regulatory requirements
• URS and cleanrooms
• Cleanroom design
• Types of contaminants
• Room classification by standard and application
• Separations, flows and pressure cascades
• Construction and architectural finishes
• HVAC design for sterile products
• Designing for highly potent products
• Personal protective equipment
• Commissioning and validation
• Risk-based prequalification of utilities (purified water, pure steam, clean-in-place)
• Quiz and case studies (30 minutes)