Certifications and quality standards

The World Health Organization publishes Good Manufacturing Practice guidelines that set the minimum expectations for how medicines are made, tested and released: clean, controlled facilities, qualified staff, validated processes and full batch records.

WHO-GMP is the basis of the WHO Certification Scheme, under which a Certificate of Pharmaceutical Product (COPP) is issued for medicines moving in international trade. Many national regulators in Africa, Asia and Latin America ask for it when you register or import a product.

For a distributor, a WHO-GMP certified facility is usually the starting point for product registration in your country.

EU-GMP is the standard that applies to medicines made for the European market, set out in the European Union's Good Manufacturing Practice guidelines. It is one of the strictest and most widely recognised benchmarks for pharmaceutical quality.

Many regulators outside Europe treat EU-GMP as a mark of a mature quality system, which can make registration and tenders easier.

EU-GMP certified manufacturing gives you the strongest quality story when you register products or bid for tenders.

ISO standards describe how an organisation manages quality. For manufacturers, the best known is ISO 9001 for quality management systems, which covers documented procedures, internal audits, corrective actions and continual improvement.

ISO certification does not replace GMP. It sits alongside it and shows that quality is managed as a system across the whole business, not only on the production floor.

ISO certification shows consistent processes from order to delivery.