(1997; 248 pages) [French]
5. Stability report
A stability report must be established for internal use, registration purposes, etc., giving details of the design of the study, as well as the results and conclusions.
The results should be presented as both a table and a graph. For each batch, the results of testing both at the time of manufacture and at different times during storage should be given. A standard form should be prepared in which the results for each pharmaceutical preparation can be summarized (see Appendix 2).
The stability of a given product, and therefore the proposed shelf-life and storage conditions, must be determined on the basis of these results.