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

for submission of PSFs do not apply. In addition, the site audit will take place in
parallel with quality control tests of samples while the results of tests are pending.
There should be maximum flexibility in this process. For example, review of the
dossier and testing of samples will be concomitantly performed and the site audit will
be conducted as soon as the dossier review is completed. As in the streamlined
approach described under section 4, consideration should be given to review of
information provided by the relevant regulatory authority with the manufacturer’s
permission (including inspection reports), and to results of tests performed by the
relevant NRA/NCL to facilitate the evaluation process.
6 Special considerations for accepting submissions of
vaccines manufactured at multiple sites or in different
countries
It is a precondition of any submission of vaccines for prequalification evaluation that
the NRA responsible for the regulatory oversight of the product must be assessed by a
WHO team with respect to its compliance with the six critical functions identified by
WHO. The functionality status of the NRA also needs to be sustained with time.
Due to the increasing diversity and complexity of the vaccines that can be
manufactured at multiple sites, including different countries, WHO has to ensure that
the regulatory oversight is fully exercised and that responsibilities are clearly defined
at all stages of production by the relevant functional NRAs. Certain criteria will be
applied, as described here.
The assessment evaluation will be product-specific, as for vaccines produced by one
company at a single site or in one country.
If a company formulates and/or fills from bulks (company A) purchased from
different sources (companies B and C) each of these final products is considered as a
unique product and will be prequalified separately.
25