GMP

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. GMP aims to minimize risks that cannot be eliminated by final product testing alone, such as contamination, mix-ups, and failures in quality. It applies to a wide range of products, including pharmaceuticals, biologics, medical devices, cosmetics, and food ingredients. Compliance is required by regulators and is enforced through inspections, certifications, and penalties.

Core GMP principles include a quality management system with defined targets and continuous improvement; qualified personnel and appropriate hygiene; suitable facilities and properly validated equipment and processes; documented procedures and batch traceability; controlled purchasing and supplier qualification; calibration, maintenance, environmental controls; change control and handling of deviations; corrective and preventive actions; and regular audits to verify compliance.

Regulatory scope and enforcement: In many jurisdictions, GMP applies to the manufacture, storage, and distribution of products. Inspections by authorities such as the U.S. Food and Drug Administration, the European Medicines Agency, and other national agencies determine compliance. Nonconformances can lead to product recalls, import holds, fines, or criminal penalties, and may halt production until corrective actions are implemented.

Global landscape: GMP guidelines exist in multiple forms, including EU GMP, US cGMP, and WHO GMP. ICH guidelines such as Q7 (GMP for active pharmaceutical ingredients) and Q10 (pharmaceutical quality system) support harmonization. While terminology varies, the core objective remains to ensure product safety and quality across borders.