Quality assurance

Quality assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. With regard to pharmaceuticals, quality assurance can be divided into four major areas: quality control, production, distribution, and inspections. The development of norms, standards and guidelines to promote quality assurance is an integral part of WHO’s Constitution and has been endorsed and supported through numerous World Health Assembly resolutions, and more recently in those on the Revised Drug Strategy.

Quality Assurance terminology

Norms, standards and guidelines

Important key elements are quality assurance guidance texts in the areas of production, testing, and distribution of medicines. These 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.

Related links

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