Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #687660

    IATE #3637052
    saintréith mhicribhitheolaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Beidh saintréithe micribhitheolaíocha na foirme cógaisíochta i ndáil le táirgí neamhsteiriúla agus steiriúla i gcomhréir le Pharmacopoeia Eorpach agus déanfar iad a dhoiciméadú mar a oideasaítear iad in Pharmacopoeia Eorpach.' Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    microbiological attribute
    en
    Definition characteristic concerning the microbiological quality of a medicinal product in its specific dosage form Reference "COM-Terminology Coordination, based on:- EMA. 'ICH Topic Q 8 (R2). Pharmaceutical Development. Step 5' (17.2.2023). EMEA/CHMP/167068/2004 - ICH. June 2009- SGS Life Science Services. 'Pharmaceutical Laboratory Services' (17.2.2023)"
    Comment i.e.- Container-Closure and Package integrity.- Preservative Effectiveness. - Justification for not having a microbial limit specification for a non-sterile drug product, drug substance or excipient