Aseptic Biopharmaceutical Manufacturing

Aims: To provide an introduction to the basic requirements of aseptic biopharmaceutical manufacture.

Outline Syllabus:

• Understanding basic concepts of “fill and finish”
• Regulatory requirements for QA/QC for biopharmaceuticals
• HVAC and critical facility design requirements
• Lyophilization for biopharmaceuticals
• Validation considerations for product analysis
• QA/QC for biopharmaceutical product release
• Quality Management requirements for biopharmaceuticals

Learning Outcomes:

On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• Understand the basic theory behind the aseptic “fill and finish” unit operation
• Identify typical unit operations associated with aseptic operations
• Understand HVAC and critical facility design considerations for a parenteral facility
• Identify and understand common design concerns associated with “fill and finish” equipment
• Understand basic environmental and process validation requirements
• Identify basic Quality Management requirements for biopharmaceutical manufacturing

(2) Discipline skills  

• Prepare a compliant high-level Quality Management System for a “fill and finish” manufacturing operation
• Audit environmental monitoring procedures
• Prepare a process validation strategy for a “fill and finish” operation