US-FOCUSED, CONDENSED PROOF OF CONCEPT VERSION
The BioPhorum Particulate Control Workstream has developed a standardized methodology and risk classification tool for particle classification in biopharmaceutical parenteral products.
“The methodology reduces the potential exposure that industry might experience from regulators and demonstrates that companies have a strong scientific approach to how they assess risk and classify visible particles,” says Scott Ewan, Facilitator of the Particulate Control Workstream.
The proof of concept version allows companies to underpin their particle classification practices with a rational, risk-based approach. It will not change how companies classify visible particles, but will provide a framework to support their current classifications.
It assesses a range of patient risk factors, such as the route of administration, and applies a simple scoring system to calculate an overall risk score for a visible particle in a product or presentation.
If challenged by regulators or internal QA teams, the methodology will help companies rebuff demands to change particle classifications using an assessment of risk, which may save batches from being destroyed if a classification is unnecessarily severe.
The driver for developing the methodology was a lack of industry guidance on how to apply criticality to visible particles. A BioPhorum survey in 2016 found that many different approaches existed but few, if any, companies had a scientific rationale for their approach.
During the methodology’s development, the Workstream took advice from medical and safety leads from member companies. Special mention should go to Dr John Ayres (who at the time was Senior Medical Director at Eli Lilly) who highlighted that the medical risk of visible particles may be overstated or was, at best, misunderstood.
The Proof of Concept version of Standardized Methodology and Risk Classification Tool can be downloaded here.
An explanatory article about the methodology was published on Pharmaceutical Online here.
The Workstream is developing version 2 of the methodology to expand the approach and address issues in a more global context. It will have a more comprehensive scope and a bias in applying the method in investigations.