USP Tightens Supply Chain Controls with Risk-Based Vendor Qualification
This article was originally published in The Gold Sheet
Executive Summary
USP biologics supply chain standards focusing on vendor qualification, not just testing - and a risk-based approach to both. Ancillary materials chapter four years ago set new ground rules with four risk tiers, now being applied in specific chapters for vaccines, Protein A, cytokines and more. Life Technologies' global sourcing and risk mitigation strategies explained. How BD Biosciences qualifies vendors. Building culture media relationships. Third revision of heparin monograph under way as USP seeks to further tighten controls against economically motivated adulteration.