Accepting any identified and evaluated risk is “taking a smart risk.” The acceptance decision, before or after mitigation, is a complex and sometimes difficult choice that is based on the information generated during the ICH Q9 quality risk management (QRM) exercise along with many subjective viewpoints impacted by previous experience, knowledge, risk appetite, and bias. This paper provides an approach for understanding and making acceptance decisions centered around the risk-rating methods that define the severity (harm) and uncertainty (likelihood) of the risk’s consequence occurring. It also builds on concepts developed in the first two parts of this QRM series to provide an overall framework for identifying, evaluating, managing, and accepting a wide variety of biopharmaceutical development and manufacturing risks…
Tag: <span>risk rating</span>
This paper, the second in a three-part series on ICH Q9 quality risk management (QRM), uses a process-based risk structure to identify product quality risks from variability in input parameters and process behavior. This paper outlines a method to identify the three types of input parameters and how they can be placed into an ICH Q8 defined design space structured to clearly categorize and control the input parameters such that they can be evaluated for their impact on product critical quality attributes (CQAs). Based on their placement in the well-structured design space, the parameters are rated using a risk severity and uncertainty index to calculate a risk rating for review and acceptance. The process-based risk structure can also be used to mitigate the likelihood of the risk consequence by modifying the processes to manage the uncertainty of the input parameters and control the process’s behavior…