Statistical Evaluation Strategy for the Long-term Stability Data of Vaccine

The analysis of the long-term stability data of vaccine products is an important basis for the evaluation of product stability, the basis for the accurate formulation of the shelf-life, and also one of the factors to ensure the quality and safety of vaccines. Aiming at the scientific problems of stability data evaluation in vaccine industry, based on the guiding principles of stability test investigation and data analysis of ICH Q5C and ICH Q1E, this paper tool the 36 months long-term stability data analysis of rabies vaccine(human diploid cell) for human use as an example, expounded the statistical analysis method of long-term stability data, and preliminarily discussed the formulation method of stability internal control line and alert line. The purpose of this study is to provide ideas and examples for standardizing the evaluation of stability and validity, and to ensure the safety and reliability of vaccine quality.