Division 5.1 Methods for the analysis of the preparation

Methods, which must be described in full, must be provided for the identification and the determination of the content of the micro-organism in the preparation. In the case of a preparation containing more than one micro-organism, methods capable of identifying and determining the content of each one should be provided.

Methods to establish regular control of the final product (preparation) in order to show that it does not contain other organisms than the indicated ones and to establish its uniformity.

Methods to identify any contaminating micro-organisms of the preparation.

Methods used to determine the storage stability and shelf life of the preparation must be provided.