Procedure for assessing the acceptability, in principle, of vaccines ...

If, as a result of the reassessment, it is found that a vaccine no longer complies with
the WHO-recommended standards, the vaccine will be removed from the list. Failure
of a manufacturer to participate in the reassessment procedure will also lead to
removal from the list.
10 Monitoring continued compliance with specifications
through targeted testing
Samples of lots supplied through United Nations agencies will be selected at least
once a year for testing of final product characteristics by WHO-contracted
laboratories. An appropriate number of samples (between 25 and 200, depending on
the vaccine type and presentation offered) of three to five lots selected by WHO from
a list of products supplied to United Nations agencies will be requested from the
manufacturer. The manufacturer will provide lot summary protocols and the
NRA/NCL release certificate as appropriate for review. Manufacturers should commit
to keeping an adequate number of retention samples for this testing programme.
Manufacturers will, in any case, be contacted for follow-up actions in case of failure
to meet specifications.
In the event of failure to meet the established criteria, WHO will investigate the
problem and provide the United Nations agency with written information, copied to
the manufacturer and the NRA, on the actions that need to be taken.
11 Monitoring vaccine quality complaints or AEFIs from
the field
Vaccine quality complaints
In case of vaccine quality complaints, WHO will conduct an investigation and may
perform independent testing after review of the relevant documentation, including
review of the temperature monitoring devices, the testing results and related data.
In case of complaints from NCLs in the receiving countries, the testing results and
related documentation (i.e. validation reports, standard operating procedures and
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