Simplifying the Route to GMP with a Risk-Based Approach to Single-Use Implementation

This special report provides insights into regulatory guidelines for SUS implementation in biopharmaceutical manufacturing. The discussion encompasses four pillars: forming a regulatory strategy, addressing flexible radiation-sterilization processes, assessing E&L, and assuring integrity and robustness. It also includes a customer case study demonstrating how Sartorius Confidence validation services used a risk-based approach to carry out a safety assessment of leachables risk for a client’s SUS-based manufacturing process. The guidance given in this report is meant to help enable a data-driven, risk-based approach to implementing SUS for protection of drug quality and patient safety.