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

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4 5 oversight. Validation of the critical tests is in progress • Review of the trends of the testing results of the manufacturer (if applicable) • Agreement with the NCL to validate the tests during the prequalification evaluation • Review of the method validation of the manufacturer and the control chart of the reference used in the manufacturer's assays may be required • Agreement to perform and provide results to WHO before prequalification is granted 64 • Transfer of the relevant method by the manufacturer to the relevant laboratories through WHO
6 7 8 Table 1 (continued) III IV Category Criteria WHO requirements/testing approach Requirements from the Traditional vaccine released by a competent NRA/NCL responsible for the regulatory oversight. NCL is performing the critical tests on a regular basis Novel or traditional vaccine NRA/NCL responsible for the regulatory oversight does not perform • 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 the NCL and the manufacturer • Review the control chart of the reference used in the manufacturer’s and the NCL’s assays • Review of United Nations tender aspects through samples of the vaccine in the final packaging presentation (to be submitted with the PSF) • Testing by WHO-contracted laboratories before the prequalification is granted • Agreement with the NCL to validate the tests 65 manufacturer before prequalification is granted • Detailed standard operating procedures for testing the product characteristics (relevant tests) • Biological reagents and reference materials for the tests by WHO- contracted laboratories • 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
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Procedure for assessing the accepta
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Acronyms The following acronyms are
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The prequalification procedure esta
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• The candidate vaccine meets the
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Such meetings are important for dis
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immunization programmes and vaccine
Page 13 and 14: As soon as the PSF is accepted and
Page 15 and 16: manufacturer, to organize an abbrev
Page 17 and 18: with both the WHO requirements and
Page 19 and 20: o review and approval of variations
Page 21 and 22: − confirmation that the vaccine m
Page 23 and 24: collaborative effort. Special atten
Page 25 and 26: for submission of PSFs do not apply
Page 27 and 28: In cases where the vaccine manufact
Page 29 and 30: WHO reserves the right to take appr
Page 31 and 32: C. The manufacturer should provide
Page 33 and 34: If, as a result of the reassessment
Page 35 and 36: In the event of situations as descr
Page 37 and 38: identifying the confidential inform
Page 39 and 40: Authors The proposals for the revis
Page 41 and 42: Geneva, Switzerland; Dr U Rosskopf,
Page 43 and 44: Acknowledgments Acknowledgements ar
Page 46 and 47: Appendix 1 The product summary file
Page 48 and 49: 3.3 Describe ventilation systems in
Page 50 and 51: For recombinant vaccines, a descrip
Page 52 and 53: 7.3 Provide information on stabilit
Page 54 and 55: particular attention to any data th
Page 56 and 57: 9.3 Summarize the arrangements and
Page 58 and 59: Appendix 2 Flowcharts of WHO prequa
Page 60 and 61: Request/supply of Additional Data Y
Page 62 and 63: Satisfactory Completion of PSF revi
Page 66 and 67: 9 10 the critical tests • Review
Page 68 and 69: 68 WHO/BS/10.2155 Page 68 1) An app
Page 70 and 71: 70 WHO/BS/10.2155 Page 70 http://ww
Page 72 and 73: 72 WHO/BS/10.2155 Page 72 1) may ha
Page 74 and 75: 74 WHO/BS/10.2155 Page 74 meeting o
Page 76 and 77: the meeting or work? 4a Patents, tr
Page 78: true and complete to the best of my
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