GMPetterlevelse

GMPetterlevelse refers to the degree to which an organization adheres to Good Manufacturing Practice (GMP) guidelines in the production and testing of products intended for human use or consumption. GMP covers all aspects of manufacturing, including quality management, personnel hygiene, facilities and equipment, validated processes, and rigorous documentation. The aim is to ensure product safety, quality, and consistency while minimizing risks such as contamination, mix-ups, and errors.

Regulatory frameworks for GMP vary by region but share common goals. In the United States, current good manufacturing practice (cGMP) is enforced by the FDA. In the European Union, EU GMP guidelines, overseen by national authorities and the EMA, are harmonized with international standards through organisations like PIC/S. Internationally, guidelines are further aligned by bodies such as ICH for active pharmaceutical ingredients and by WHO for public health products. Compliance is typically demonstrated through regular inspections and the maintenance of a comprehensive quality management system.

Key elements of GMP include a quality management system, trained personnel, validated facilities and equipment, controlled production environments, written procedures and thorough batch records, change control, deviation handling with corrective and preventive actions (CAPA), supplier qualification, and robust release, distribution, and traceability controls. Environmental monitoring, sanitation, and preventive maintenance are also integral parts of GMP.

Enforcement and impact: Regulatory authorities assess GMP compliance through inspections, and non-compliance can lead to actions ranging from warnings and recalls to fines or licensing suspensions. GMP is applicable across industries such as pharmaceuticals, biologics, dietary supplements, cosmetics, and certain medical devices, with specifics adapting to product category and jurisdiction.