Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities. WHO Expert Committee on Biological Standardization, Sixty-first Report - WHO Technical Report Series, No. 978, Annex 2
(2013; 32 pages)


Recommendations published by WHO are intended to be scientific and advisory. Each of the following sections constitutes guidance for national regulatory authorities (NRAs) and for manufacturers of biological products. If an NRA so desires, these recommendations may be adopted as definitive national requirements, or modifications may be justified and made by the NRA. It is recommended that modifications to these recommendations be made only on condition that the modifications ensure that the vaccine is at least as safe and efficacious as that prepared in accordance with the recommendations set out below.

The lot release of vaccines by regulatory authorities is part of the regulation of vaccines and involves the independent assessment of each lot of a licensed vaccine before it is released on to the market. This assessment is based, as a minimum, on the review of manufacturers’ summary protocols. It may be supplemented by other documents such as the release certificate from the responsible national regulatory authority (NRA) or national control laboratory (NCL) and, in some circumstances, by testing that is independent of the manufacturers’ qualitycontrol testing.

WHO provides support for lot release programmes through the provision of written standards and measurement standards, strengthening the lot release function of NRAs and providing training. However, a need for further guidance was identified at a WHO consultation held in Ottawa in 2007. This document provides recommendations and strategies for the lot release of vaccines by the NRAs/NCLs of producing and procuring countries. It should be read in conjunction with the recommendations/guidelines for specific products (e.g. recommendations for bacille Calmette–Guérin (BCG), oral poliomyelitis (OPV), measles, mumps and rubella (MMR), diphtheria–tetanus–pertussis (DTP), human papilloma virus (HPV) and rotavirus vaccines).

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