This standardized methodology (SM) provides a tool to implement a risk-based output for classification of visible particles to support decision-making during particle investigations. 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 the disposition of a given batch and provides a framework through which the tool can be used to demonstrate the impact of risk mitigation.
This methodology allows for the holistic determination of the overall risk of visible particles in injectable drug products. The comprehensive SM clarifies the approach to classifying visible particles in parenterals for adoption throughout the clinical and commercial pharmaceutical manufacturing industry.
The application of this SM will be encouraged across the membership of BioPhorum’s Visual Inspection workstream. When data are available, case studies and examples will be published to illustrate some of the opportunities made possible through the approach.