This article published in the PDA Journal of Pharmaceutical Science and Technology discusses challenges encountered when implementing bio-fluorescent particle counting systems as a routine microbial monitoring tool , and the perspective from a consortium of four industry working groups on navigating these challenges.
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BioPhorum’s Visual Inspection workstream has invested considerable time and effort to add clarity to the uncertainty around how to assess the risk of atypical particles during investigations. The team’s Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products was recently published by BioPhorum and provides practical, risk-based guidance to support the decision-making process....
Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products
This paper provides a framework to support investigations related to atypical or frequently occurring particles observed during VI or related to field complaints – which require detailed and systematic assessment of risk to the quality of the batch. The proposal for a standardized risk investigation methodology outlined in this paper may support such risk assessments, where the total risk related to foreign particles is assessed by considering a variety of risk factors (type, frequency, etc.) and applying a failure mode and effects analysis (FMEA) tool to calculate a total risk-based score.
Particle classification: An industry-wide standardized methodology and risk classification tool for PC in biopharmaceutical parenteral products
All companies need to classify the risks various types of visible particles provide. This is not a simple task and without a well supported, scientific basis companies lay themselves open to regulatory challenges and sometimes have to commit to questionable controls. The proof of concept, developed by a large group of industry practitioners, 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. The methodology 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. When challenged by regulators or internal QA teams, the methodology helps companies respond to demands to change particle classifications using an assessment of risk, which in turn may save batches from being destroyed if a classification is unnecessarily severe.