Risk Management in Sterile Manufacturing

Sterility assurance is a critical component in the planning and manufacturing of pharmaceutical products. Good risk management consists of identifying and assessing risks prior to the manufacturing process as well as taking measures during the production process to control, mitigate, or eliminate risks. An upcoming educational webcast by Pharmaceutical Technology, Risk Management in Sterile Manufacturing, will examine best practices for risk management in sterile manufacturing.

Risk management and its tools are crucial for capturing product and process knowledge, understanding criticality, and creating a plan of action to evaluate and mitigate risk. A three-member panel will examine these issues in further detail. Dr. Mike Long, MBB and director and senior consultant with ConcordiaValSource LLC, will speak on quality-by-design principles in sterile manufacturing. He is also co-chair of the Parenteral Drug Association’s (PDA) Risk Management Task Force and member of PDA’s Science Advisory Board. Hal Baseman, chief operating officer and principal at ValSource LLC, will examine FDA’s recent process validation guidance and its implications with respect to sterile manufacturing. He is also chair-elect of PDA’s board of directors, vice-chair of the PDA Science Advisory Board, and co-leader of the PDA Process Validation Interest Group. Michael Curry, director of operations at the DPT Lakewood Center of Excellence for Aseptic and Specialty Products, will discuss ways to identify, assess, and mitigate risk in a sterile manufacturing environment.