WHO Technical Report Series

The WHO Technical Report Series makes available the findings of various international groups of experts on a broad range of medical and public health subjects. It includes the reports of the annual meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP). An Expert Committee is the highest official advisory body to the Director-General of WHO, as well as to all its Member States. An Expert Committee is established by the WHO World Health Assembly or by an Executive Board decision. It is governed through rules and procedures that are strictly adhered to. ECSPP was established at the first World Health Assembly, in 1948, to provide recommendations and tools to ensure the quality of medicines: from their development phase to their final distribution to patients. The development of norms, standards and guidelines to promote quality assurance and quality control is an integral part of WHO’s Constitution and a unique responsibility.

Guidelines relating to medicines quality assurance are drafted by pharmaceutical specialists, in consultation with the WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations, other specialists from industry, national institutions and nongovernmental organizations. Preparation of guidelines generally incorporates an extensive consultative procedure. The draft guidelines are evaluated by ECSPP at its annual meeting. If considered to be appropriate they are adopted as international standards. Alternatively, ECSPP may request that a draft guideline be revised.

The WHO Technical Report Series includes all guidelines that have been adopted by ECSPP. They are appended as annexes to ECSPP’s annual reports, each of which is published as a WHO Technical Series report. Many of these annexes underpin the procedures and activities of WHO medicines prequalification and therefore serve as valuable references for manufacturers, regulators and procurers.

WHO Technical Report Series documents relating to development, production, distribution, inspection and quality control of medicines can be found on the guidelines section of the WHO web pages dealing with quality assurance of medicines. All Technical Report Series documents issued by ECSPP are publicly available.