Single use system qualification for viral safety in upstream and downstream processes Single Use System Qualification for Viral Safety in Upstream and Downstream Processes Regulatory Affairs Context The qualification of single-use systems and vendor qualifications for virus filter resins is a critical component in ensuring the viral safety of biopharmaceutical products. Regulatory authorities, such as the FDA, EMA, and MHRA, provide specific guidelines and expectations regarding the qualification of suppliers involved in the production of these systems. As the industry shifts towards single-use technologies, it is imperative for regulatory affairs professionals to effectively manage vendor qualifications while ensuring compliance with…

Building a Risk-Based Vendor Monitoring Plan for Virus Filters and Resins Building a Risk-Based Vendor Monitoring Plan for Virus Filters and Resins Context The increasing complexity of biopharmaceutical manufacturing demands rigorous standards for ensuring the safety and efficacy of products. Among the critical components in this landscape are virus filters and resins used in the purification processes of biological products. Regulatory Affairs (RA) professionals play an essential role in ensuring compliance with regulations and guidelines surrounding vendor qualification and monitoring. The emphasis on viral clearance and biological safety validation has prompted agencies such as the FDA, EMA, and MHRA to…