Supporting particle investigations with risk-based decision-making

There is no clear or consistent guidance on how companies should approach investigations, and as a result, practices vary across the industry. However, there is a growing expectation, not limited to particles, that risk-based approaches be taken to address potential issues.

BioPhorum’s Visual Inspection team published a proof-of-concept A standardized methodology to support particle investigations and classifications in biopharmaceutical parenteral products at the end of 2021. The methodology is not intended to replace established investigation procedures but instead is a valuable add-on tool to generate a risk-based output to support decision-making during particle investigations.

The criteria built into the approach allow multi-disciplinary investigation teams to examine risk through a series of logical steps, removing some of the uncertainty inherent in decision-making about the disposition of a batch. Through evaluation of the severity of a particle, its rate of occurrence, and probability of detection, it is possible to establish the relative risk of a visible particle to a given batch and provide a framework through which the tool can be used to demonstrate the impact of risk mitigation, removing some of the uncertainty inherent in decision making.