the various stages of manufacture (including production of the antigen and purification procedures) so that an assessment can be made of the reproducibility of the manufacturing procedure and of the risks of adverse effects on the finished products, such as microbiological contamination; the validation of key stages in the production process shall be demonstrated and the validation of the production process as a whole shall be demonstrated with provision of results of three consecutive batches produced using the method described,
céimeanna éagsúla de mhonarú (lena n-áirítear táirgeadh na nósanna imeachta antaiginí agus íonúcháin) sa chaoi gur féidir measúnú a dhéanamh ar in-atáirgtheacht an nós imeachta monaraíochta agus ar na rioscaí go mbeidh éifeachtaí díobhálacha acu ar na táirgí críochnaithe, amhail éilliú micribhitheolaíoch; léireofarbailíochtú ar phríomhcéimeanna den phróiseas agus léireofar bailíochtú ar an bpróiseas táirgthe ar an iomlán agus déanfar foráil maidir le torthaí ar thrí bhaisc as a chéile arna dtáirgeadh trí úsáid a bhaint as an modh a bhfuil tuairisc air,