A raw material is any starting material, reagent, excipient, consumable, or component used in the manufacture of a biopharmaceutical product that may directly or indirectly impact product quality, safety, or efficacy. In GMP-compliant biomanufacturing, raw materials must be qualified, tested, and approved against defined specifications prior to use, and their traceability, supply chain security, and vendor qualification are subject to strict regulatory oversight by agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Critical raw materials — such as cell culture media, plasmid DNA, viral vectors, and enzymes — require enhanced risk assessment and control strategies in accordance with ICH Q7 and ICH Q11 guidelines.
