GMPcompliance

GMP compliance, sometimes written as GMPcompliance, refers to adherence to Good Manufacturing Practice (GMP) standards intended to ensure products are consistently produced and controlled according to quality standards. It applies to pharmaceutical products, biologics, vaccines, medical devices where GMP principles are required, as well as dietary supplements and cosmetics in jurisdictions with GMP rules.

Regulatory oversight is provided by national authorities such as the U.S. Food and Drug Administration (FDA) with current good manufacturing practices (cGMP), the European Medicines Agency (EMA), and corresponding agencies worldwide, often complemented by WHO guidelines. Compliance is verified through inspections, audits, and documentation reviews; non-compliance can lead to enforcement actions, product recalls, or shutdowns.

A GMP-compliant operation typically maintains a Quality Management System (QMS) covering facilities, equipment, materials, and personnel; documented procedures; production and process controls; validation and qualification of processes and systems; change control; deviation management and corrective and preventive actions (CAPA); supplier qualification; material traceability; batch records; in-process and final testing; appropriate storage, packaging, and labeling.

GMP compliance follows a lifecycle approach from product development through manufacturing, packaging, distribution, and post-market surveillance. It emphasizes risk management, ongoing training, internal and supplier audits, and continuous improvement to address deviations and emerging risks.

Global harmonization efforts seek to align GMP expectations across jurisdictions, enabling mutual recognition and smoother market access. While the term GMP is widely used, specific requirements vary by product category and regulatory authority, and manufacturers must implement location-specific compliance programs.