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WHO Technical Report Series

WHO Technical Report Series

The WHO Technical Report Series (TRS) makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects. It includes the  reports of the annual meetings of the WHO Expert Committee on Biological Standardization. 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. ECBS has met every years since 1947 was established at the first World Health Assembly and is responsible for the establishment of the WHO International Biological Reference Preparations and for the adoption of the WHO Recommendations and Guidelines. 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 vaccines quality assurance are drafted by pharmaceutical specialists, in consultation with other specialists from industry, national institutions and nongovernmental organizations. Preparation of guidelines generally incorporates an extensive consultative procedure. The draft guidelines are evaluated by ECBS at its annual meeting. If considered to be appropriate they are adopted as international standards. Alternatively, ECBS may request that a draft guideline be revised.

The WHO Technical Report Series includes all guidelines that have been adopted by ECBS. 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 vaccines prequalification and therefore serve as valuable references for manufacturers, regulators and procurers. For example, Annex 2 of WHO Technical Report Series 957, WHO Expert Committee on Specifications for Pharmaceutical Preparations, Forty-fourth Report (published in 2010) concerns WHO good manufacturing practices (GMP) for active pharmaceutical ingredients. WHO inspections of the manufacturing sites of active pharmaceutical ingredients and finished pharmaceutical products, undertaken as a component of evaluation for WHO prequalification, are based on WHO GMP.

The guidelines most relevant to WHO vaccines prequalification are listed and accessible below. All Technical Report Series documents issued by ECBS are publicly available.

Guidelines on stability evaluation of vaccines
WHO Technical Report Series, No. 962, Annex 3.