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

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Appendix 3 Testing approach for initial evaluation for prequalification
Table 1
Category Criteria WHO requirements/testing approach Requirements from the
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II
Novel vaccine or
new combination
released by a
competent
NRA/NCL
responsible for the
regulatory
oversight. NCL is
performing the
critical tests on a
regular basis
Novel vaccine
released by a
competent
NRA/NCL
responsible for the
regulatory
• Review of United Nations tender aspects through
samples of the vaccine in the final packaging
presentation (to be submitted with the PSF)
• Review of the testing results by the manufacturer
and the NCL (raw data) of at least three lots
formulated from consecutive bulk lots
• Review of the trends of the testing results of both
NCL and manufacturer (if applicable)
• Review of the control chart of the reference used
in manufacturer's and NCL's assays
• Review of the method validation of the
manufacturer and the NCL may be required
• Review of United Nations tender aspects through
samples of the vaccine in the final packaging
presentation (to be submitted with the PSF)
• Review of the testing results by the manufacturer
(raw data) of at least lots formulated from
consecutive bulk lots
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manufacturer before prequalification
is granted
• Detailed standard operating procedures
for testing the product characteristics
(relevant tests)
• Biological reagents and reference
materials for the validation of the tests
by WHO-contracted laboratories
• Transfer of the relevant method by the
manufacturer to the relevant laboratories
through WHO
• Detailed standard operating procedures
for testing the product characteristics
(relevant tests)
• Biological reagents and reference
materials for the validation of the tests
by WHO-contracted laboratories
Requirements post-
prequalification
• Commitment from the
manufacturer to keep
retention samples for
testing by WHO-
contracted laboratories
• Testing of the vaccine
through the targeted
testing programme