Regulatory
WHO-GMP
Definition
GMP based on World Health Organization guidelines, often certified by national regulators for exports under the WHO certification scheme.
The World Health Organization publishes GMP guidelines that many countries use as their national standard. Under the WHO certification scheme on the quality of pharmaceutical products, the regulator of the exporting country can issue a certificate of pharmaceutical product (CoPP) confirming the product is authorised and the site complies with GMP.
In India, WHO-GMP certificates and CoPPs are issued by CDSCO and state licensing authorities after inspection. Importing countries in Africa, Asia and Latin America commonly ask for them.
Related terms
- GMP (good manufacturing practice)Rules for making medicines, APIs, food and cosmetics so that every batch is consistently produced and controlled to its quality standard.
- CDSCOThe Central Drugs Standard Control Organisation, India's national regulator for drugs, medical devices and cosmetics imports.