GMP - Good Manufacturing Practice

GMP Certification is a regulatory compliance system confirming that manufacturers implement comprehensive quality management practices covering facility design, equipment maintenance, personnel training, raw material controls, production processes, and quality assurance procedures. This certification ensures products meet safety, quality, and efficacy requirements through systematic controls at every manufacturing stage from raw material receipt through final product distribution. GMP standards mandate proper facility sanitation, environmental monitoring, contamination prevention, batch documentation, equipment calibration, and employee hygiene protocols preventing defects, mix-ups, and contamination that could compromise product quality or consumer safety.

The certification process involves rigorous facility audits, process validation, standard operating procedure review, quality system assessment, and ongoing compliance monitoring by regulatory authorities or accredited certification bodies. Certified manufacturers must maintain detailed batch records, implement robust change control systems, conduct regular internal audits, establish complaint handling procedures, and maintain product traceability throughout distribution chains. GMP certification requires continuous compliance with evolving regulations including FDA, EMA, WHO, or country-specific standards depending on target markets and product categories.