Sustainability of the PQ system

THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE

2.G Stability

Stability testing should be performed at different stages of production, namely on single harvests, purified bulk, final bulk, and final lot, if applicable. Stability-indicating parameters should be defined or selected appropriately according to the stage of production. It is advisable to assign a shelf-life to all in-process materials during vaccine production, in particular intermediates such as single harvests, purified and final bulk.

The stability of the vaccine in its final container and at the recommended storage temperatures should be demonstrated on at least three lots of final product tested at regular intervals until the end of the shelf life.

A description shall be given of the tests undertaken to support the shelf life proposed. These tests shall always be real-time studies; they shall be carried out on a sufficient number of batches produced according to the described production process and on products stored in the final container(s); these tests include biological and physico-chemical stability tests.

The potency of the finished product should be controlled at regular intervals until the end of the shelf life using the batch potency test mentioned under 2.E.3. (direct or indirect tests).

The conclusions shall contain the results of analyses, justifying the proposed shelf life under all proposed storage conditions.

Stability data obtained from combined products may be used as preliminary data for derivative products containing one or more of the same components.

The efficacy of any preservative system shall be demonstrated.

In addition, a list of final lots internally rejected in the previous 2 years should be provided including the reasons for rejection.