Division 4.1 Methods for the analysis of the micro-organism as manufacturedF1

Methods for the identification of the micro-organism,

Methods for providing information on possible variability of seed stock/active micro-organism,

Methods to differentiate a mutant of the micro-organism from the parent wild strain,

Methods for the establishment of purity of seed stock from which batches are produced and methods to control that purity,

Methods to determine the content of the micro-organism in the manufactured material used for the production of formulated products and methods to show that contaminating micro-organisms are controlled to an acceptable level,

Methods for the determination of relevant impurities in the manufactured material,

Methods to control the absence and to quantify (with appropriate limits of determination) the possible presence of any human and mammalian pathogens,

Methods to determine storage stability, shelf-life of the micro-organism, if appropriate.