What is Good Manufacturing Practice (GMP) in pharmaceutical production?

Good Manufacturing Practice (GMP) is a system of regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards. Key GMP principles include: documented procedures for all processes; qualified and trained personnel; suitable facilities and equipment; appropriate environmental controls and cleanliness; validated processes and methods; quality control testing of raw materials and finished products; traceability through batch records; handling of deviations and complaints; and regular audits. cGMP (current GMP) reflects that standards evolve. GMP is required by regulatory agencies (FDA, EMA) and covers all aspects from raw materials to distribution. Non-compliance can result in warning letters, product recalls, or facility shutdown.