WHO quality assurance activities
WHO's quality assurance activities in norms, standards and guidelines
Quality assurance of pharmaceuticals is a major public health challenge, particularly in light of growing cross-border health issues and the international dimensions of trade. The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. The World Health Assembly has adopted many resolutions and more recently in WHO Medicines Strategy 2008-2013 requesting the organization to develop international standards, recommendations and instruments to assure the quality of medicines, whether produced and traded nationally or internationally.
Norms, standards and guidelines include guidance on: good manufacturing practices; quality assurance for regulatory approval; prequalification of medicines, laboratories, and supply agencies; model certificates for quality assurance-related activities; quality control testing; new specifications for inclusion in the Basic Tests series and the International Pharmacopoeia; and International Chemical Reference Standards; the programme on International Nonproprietary Names (INN) which is used to identify each pharmaceutical substance or active ingredient by a unique and universally accessible name.
All these elements are intended for use by national regulatory authorities, manufacturers, and other interested parties. The need to scale up access to affordable quality medicines for HIV/AIDS, TB, and malaria in developing countries has raised many challenges within the pharmaceutical world. These challenges come on top of the reality that among national regulatory authorities there is a variable capacity to interpret and apply existing norms and standards and guidelines on regulation, quality control, nomenclature, and classification of pharmaceuticals. WHO will work to strengthen and promote global norms, standards, and guidelines for the quality, safety, and efficacy of medicine.