Immunization, Vaccines and Biologicals

Manual for quality control of diphtheria, tetanus, pertussis and combined vaccines

Publication details

Number of pages: 312
Publication date: 1 May 2013
WHO reference number: WHO/IVB/11.11


Manual of laboratory for testing vaccines (WHO/VSQ/97.04) was published in 1997 for the use in the WHO EPI. Taking into account recent developments in quality control methods and revision of WHO recommendations, the manual is to be revised to reflect the progress. The revision will cover the laboratory testing methods on potency, toxicity and identity tests of diphtheria, tetanus and pertussis vaccines and the statistical analysis of the test results as well as the design of a test. This document replaces WHO/VSQ/97.04 and provides guidance to the quality control staff of national control laboratories and vaccine manufacturers. It also assists the licensing authority in evaluating the quality control part of the application dossier.