Good Manufacturing Practice (GMP)
A system of quality assurance standards ensuring pharmaceutical products are consistently produced according to established specifications. GMP covers facilities, equipment, personnel, raw materials, processes, and testing. All approved peptide drugs must be manufactured under GMP conditions.
Technical Context
GMP requirements cover: facility design (cleanroom classifications, HVAC systems, environmental monitoring), equipment qualification (installation, operational, performance qualification — IQ/OQ/PQ), personnel training and gowning, raw material testing and supplier qualification, manufacturing process validation (demonstrating consistency across 3+ batches), in-process controls (monitoring critical process parameters), quality control testing (identity, purity, potency, sterility, endotoxin), documentation (batch records, SOPs, deviation investigations, change control), and corrective/preventive actions (CAPA). For peptide drugs, GMP is particularly demanding because: peptide synthesis requires precise chemistry, purification must remove closely related impurities, and injectable formulations require aseptic processing. Regulatory inspections (FDA, EMA, MHRA) verify GMP compliance through pre-approval inspections and routine surveillance.