Supporting particle investigations with risk-based decision-making

Broadcast date

Wed, Nov 30, 2022

 

Presented by

    Valerie Rautureau - Eli Lilly
    Marcel Uijlen - Organon
    Antonio Burazer - Takeda
    Scott Ewan - BioPhorum

 

Quick Description

The presence of visible particles in parenteral medicines is a perennial issue for the industry.
How do companies manage particles when they are found, especially when atypical in nature?
What can companies do to assess the risk of a particle, and how can a particle impact the future of a batch of a biopharmaceutical product?

Details

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.

Speakers

Valerie Rautureau

Eli Lilly

Marcel Uijlen

Organon

Antonio Burazer

Takeda

Scott Ewan

BioPhorum