About this document
Risk-Based Filter Integrity Testing for Biologics by Michele is a document available to read on EtoBox.
This document presents a risk-based approach to filter integrity testing (FIT) for low bioburden biologics drug substance manufacturers, interpreting EudraLex Annex 1 and other relevant literature. It outlines the importance of FIT in ensuring contamination control and provides a decision tree model to guide manufacturers on when and where to implement FIT. The findings suggest alignment with current industry practices and emphasize the need for a targeted strategy that enhances process reliability and pati
- Author
- Michele
- Language
- EN