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

6.3 Finished product (including diluent)
6.3.1 List routine tests performed and specifications for final product. Concise
descriptions of the method and re-test criteria are acceptable but full standard
operating procedures in English should be made available on request.
6.3.2 List assay validation activities performed.
6.3.3 List final lots internally rejected in the previous two years and reasons for
rejection.
Chapter 7: Stability
Stability studies are expected to have been designed and conducted to meet WHO
guidance (1).
7.1 Provide information on stability tests on intermediates, namely:
− information on containers for intermediate products;
− assigned shelf-life and storage conditions;
− quality control methods and specifications, and rationale for the choice of
tests for determining stability;
− identification of the dates of manufacture of the lots, the lot numbers, the
vial and dose size, and the scale of production.
Results of quantitative assays must be expressed as a numerical value with the
appropriate limits and not as “pass” or “fail”.
7.2 For each presentation, provide information on stability testing of the finished
product, namely:
− assigned shelf-life and storage conditions;
− quality control methods and specifications, and rationale for the choice of
tests for determining stability profile;
− identification of the dates of manufacture of the lots, the lot numbers, the
vial and dose size, and the scale of production.
Results of quantitative assays must be expressed as a numerical value with the
appropriate limits and not as “pass” or “fail”.
In addition to data on final product stability at the recommended storage temperature,
the accelerated stability data at elevated temperatures should be sufficient to justify
the choice of VVM for use with the product (2).
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