About Quality Assurance
Process of WHO's standards setting
In the area of quality assurance, the norms, standards and guidelines developed by WHO have been prepared through a vast global consultative process involving WHO Member States, national authorities and international agencies,. In consultation with the WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations, with specialists from industry, national institutions, nongovernmental organizations, etc.
The draft norms, standards and guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, adopted as international standards. Member States, national drug regulatory authorities (NDRAs) and pharmaceutical manufacturers, as well as international bodies such as the Global Fund to Fight AIDS, TB and Malaria (GFATM), and UNICEF, all depend on the Committee’s norms, standards and guidelines. These tools are also of fundamental importance to such high-profile initiatives as the UN Prequalification Programme, the Global Malaria Programme and Stop TB.