Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #687060

    IATE #3628204
    bailíochtú próisis Reference "Togra le haghaidh Rialachán maidir le caighdeáin cháilíochta agus sábháilteachta le haghaidh substaintí de bhunús daonna a bheartaítear lena n-úsáid sa duine agus lena n-aisghairtear Treoracha 2002/98/CE agus 2004/23/CE,CELEX:52022PC0338/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Áirithíonn bailíochtú go gcomhlíonann an táirge forbartha riachtanais an chustaiméara. Baineann an bailíochtú leis an HEX mhótarfheithicle féin agus le AFRPanna HEX mótarfheithiclí. Is féidir leis an bpróiseas seo suas maireachtáil suas le dhá bhliain agus áirítear leis tástáil saotharlainne, bailíochtú ábhair agus próisis.' Reference "Rialachán Cur Chun Feidhme (AE) 2021/582 lena bhforchuirtear dleacht frithdhumpála shealadach ar allmhairí táirgí cothromrollta alúmanaim de thionscnamh Dhaon-Phoblacht na Síne,CELEX:32021R0582/GA"
    process validation
    en
    Definition documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes Reference "EMA. 'Guideline on process validation for finished products - information and data to be provided in regulatory submissions' (16.5.2025). EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1. 21 November 2016"