Gap Analysis and Risk Assessment

Regulatory thinking is based on looking at the same data set as product development scientist, but from a different vantage point. Let us imagine that product development is the progress along a path to the destination of approval (!). The product development scientist moves along the path from one end, making decisions to proceed based on the knowledge available at that time, and the forks presented in the road. The regulatory scientist is at the other end, looking at the path coming towards the destination across the landscape. We are all on the same product development path, but the regulatory scientist is at the other end, looking at how the data supports the end goal.

With this end goal in mind, an invaluable tool is a gap analysis to define outstanding activities for the product development team. A first-in-man project may need more emphasis of the cell bank system establishment and phase 1-enabling virus clearance work, a later stage process may need to ensure robust supplies of bespoke reagents with appropriate regulatory compliance certificates. All projects will need a Critical Quality Attribute assessment. Risk assessments can be used to determine the urgency addressing these identified gaps.

Knowing that there are many variables for the characterization of a biopharmaceutical quality attributes and its process control, risk assessments, including ICH Q8 approaches, can be used to determine where new data are required.