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Hugtakasafn : Eitt hugtak
ÍSLENSKA
örverumengun
ENSKA
microbiological contamination
Svið
lyf
Dæmi
[is] Í því markmiði skal þar a.m.k. tilgreina ... hin ýmsu framleiðslustig (þ.m.t. framleiðsla mótefnavakans og hreinsunarferli) þannig að hægt sé að leggja mat á samanburðarnákvæmni framleiðsluferlisins og áhættuna með tilliti til neikvæðra áhrifa á fullbúin lyf, eins og t.d. örverumengun ... .

[en] For this purpose the description shall include at least ... 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 ... .

Skilgreining
[en] non-intended or accidental introduction of infectious material like bacteria, yeast, mould, fungi, virus, prions, protozoa or their toxins and by-products (IATE; science, 2019)

Rit
[is] Tilskipun framkvæmdastjórnarinnar 2009/9/EB frá 10. febrúar 2009 um breytingu á tilskipun Evrópuþingsins og ráðsins 2001/82/EB um Bandalagsreglur um dýralyf

[en] Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use

Skjal nr.
32009L0009
Orðflokkur
no.
Kyn
kvk.
ENSKA annar ritháttur
microbial contamination