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

manufacturer, to organize an abbreviated site audit. This would focus only on aspects
relevant to the product under evaluation that have not been addressed by the NRA that
did the inspection, including all those aspects that are specific to the United Nations
tender specifications.
For a new application, when the review of the PSF and testing have been satisfactorily
completed, WHO may assemble a team to audit the manufacturing facility. The site
audit will take place as soon as possible after satisfactory test results are available, and
usually within two months. Technical staff from the relevant United Nations agency
may elect to join the team. Otherwise, the team will be composed, as far as possible,
of the experts who reviewed the file. Team members must have expertise in the areas
of production, quality control, quality assurance, quality system and GMP. If
additional members or replacement members are needed, the curriculum vitae of the
proposed new members will be submitted to the company for clearance. The team will
cover the range of expertise required to assess the vaccine in question from the
different perspectives. A WHO staff member will lead the audit team and the
members will act, on a temporary basis, as expert advisers to WHO. In some
circumstances, leadership can be delegated to one of the external experts who will act
on behalf of WHO.
The NRA of the manufacturing country or the NRA with regulatory oversight of the
product will be invited to assign one or two staff members to join the WHO team as
observers.
A bilateral consultation meeting will be held between WHO and the NRA, either at
the beginning or at the end of the mission. The purpose of this meeting is to discuss
regulatory matters related to the vaccine in question and to lay the basis for the letters
of agreement. Topics addressed during such consultation meetings relate to
commitment for testing and release of vaccine lots for United Nations agencies, need
for feedback on findings during inspections, updates on safety and efficacy data,
variations to the marketing authorization/licence that may have been requested,
marketing authorization/licence renewals, recalls or withdrawal of lots, etc. WHO will
establish letters of agreement with all the NRAs responsible for the oversight of
prequalified products.
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