Gaois

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4 results

  1. AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|crop production · SCIENCE|natural and applied sciences|life sciences|biology|botany

    #635228

    IATE #1705239
    Saatgutpartie
    de
    Definition bestimmte, eindeutig identifizierbare, homogene, verschlossene und gekennzeichnete Menge von Saatgut Reference "Ministerium für Kultus, Jugend und Sport Baden-Württemberg: SVK-Schulung Probenahme Jonitz 2015 (9.1.2024)"
    seed lot
    en
    Definition set of seeds collected from approved basic material and processed uniformly Reference COM-Internal document: SANTE-2023-01531 (Forest Reproductive Material)
    lot de semences
    fr
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #640999

    IATE #2250568
    máistirshíol Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Master Seed | Originalsaatviren (Mater Seed)
    de
    master seed lot | master seed
    en
    Definition culture of a micro-organism distributed from a single bulk into containers in a single operation in such a manner as to ensure uniformity, to prevent contamination and to ensure stability Reference "European Commission > Enterprise & Industry > Pharmaceuticals > EudraLex (Rules Governing Medicinal Products in the European Union) > Vol 4 : Good manufacturing practice (GMP) guidelines > Glossary http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/glos4en200408_en.pdf [21.11.2012]"
    Comment A master seed lot in liquid form is usually stored at or below - 70°C. A freezedried master seed lot is stored at a temperature known to ensure stability.
    lot de semence initial
    fr
  3. SOCIAL QUESTIONS|health|pharmaceutical industry · SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|vaccine

    #636109

    IATE #1875887
    córas beart síl Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Beidh táirgeadh vacsaíní bunaithe ar chóras beart síl agus ar shíolta ceall seanbhunaithe aon uair is féidir. Maidir le táirgeadh táirgí íocshláinte tréidliachta imdhíoneolaíocha atá déanta as séiream, léireofar an áit tionscnaimh, sláinte ghinearálta agus stádas imdhíoneolaíoch na n-ainmhithe táirgthe agus úsáidfear comhthiomsuithe sainithe d’ábhair bhunaidh.' Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
    seed lot system
    en
    Definition "system according to which successive batches of a product are derived from the same master seed lot at a given passage level" Reference "European Medicines Agency (EMA). 'VICH GL50 on Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use' (27.1.2021). EMA/CVMP/VICH/582610/2009 18 February 2016"
    Comment "For routine production, a working seed lot is prepared from the master seed lot. The final product is derived from the working seed lot and has not undergone more passages from the master seed lot than the vaccine shown in clinical studies to be satisfactory with respect to safety and efficacy. The origin and the passage history of the master seed lot and the working seed lot are recorded."
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #641546

    IATE #3502643
    working seed lot
    en
    Definition culture of a micro-organism derived from the master seed lot and intended for use in production Reference "European Commission > Medicinal products > EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines (22.1.2021) > 'Glossary' (22.1.2021)"