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

United Kingdom

Original text. Later amendments are not shown.

  • 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.