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Process-Related Contaminants

Meaning

Process-Related Contaminants are unwanted substances that are inadvertently introduced into a drug product, including compounded or biologic hormone therapies, as a direct consequence of the manufacturing process itself. These impurities are distinct from degradation products of the drug molecule or microbial contamination from the environment. Examples include host cell proteins (HCPs) from recombinant production, residual solvents, catalysts, column leaching materials, or unreacted reagents used during chemical synthesis. Rigorous control and monitoring of these contaminants are mandated by cGMP regulations to ensure patient safety and prevent adverse immunological reactions.