{"id":1636,"date":"2014-03-14T00:12:38","date_gmt":"2014-03-13T23:12:38","guid":{"rendered":"http:\/\/www.hygiene-expertise.com\/de-herziening-van-bijlage-15-2\/"},"modified":"2014-03-14T00:12:38","modified_gmt":"2014-03-13T23:12:38","slug":"de-herziening-van-bijlage-15","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/nl_BE\/de-herziening-van-bijlage-15\/","title":{"rendered":"De herziening van bijlage 15"},"content":{"rendered":"

openbare raadpleging over kwalificatie en validatie<\/h2>\n
\"\u00a9<\/a>

\u00a9 Sanofi Pasteur 2008 \/ David W. Coulter Photography<\/p><\/div>\n

Opmerkingen over het ontwerp worden aanvaard tot 31 mei 2014.<\/p>\n

Momenteel wordt bijlage 15: kwalificatie en validatie van de Europese richtsnoeren inzake goede praktijken bij het vervaardigen van geneesmiddelen (EU GMP) herzien. Op 6 februari is de Europese Commissie begonnen met de openbare raadpleging van de ontwerp<\/a>tekst. Belanghebbenden worden verzocht hun opmerkingen over dit ontwerp uiterlijk op 31 mei 2014 in te dienen.<\/p>\n

Deze eerste wijziging aan bijlage 15 beoogt rekening te houden met de veranderingen aangebracht aan andere artikelen uit deel I van de richtsnoeren, namelijk aan bijlage 11, ICH Q8, Q9, Q10 en Q11 en de QWP-richtsnoeren over de validatie van processen en de veranderingen in productietechniek. De deadline voor de inwerkingtreding van de nieuwe versie werd nog niet bepaald.<\/p>\n

U kunt uw opmerkingen sturen naar ADM-GMDP@ema.europa.eu<\/a>\u00a0en\u00a0sanco-pharmaceuticals-D6@ec.europa.eu<\/a>.<\/p>\n

Bron :<\/em> \u00a0www.processpropre.fr<\/a><\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

openbare raadpleging over kwalificatie en validatie Opmerkingen over het ontwerp worden aanvaard tot 31 mei 2014. Momenteel wordt bijlage 15: kwalificatie en validatie van de Europese richtsnoeren inzake goede praktijken bij het vervaardigen van geneesmiddelen (EU GMP) herzien. Op 6 februari is de Europese Commissie begonnen met de openbare raadpleging van de ontwerptekst. Belanghebbenden worden… Read more »<\/a><\/p>\n","protected":false},"author":21,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[15],"tags":[],"class_list":["post-1636","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"yoast_head":"\nDe herziening van bijlage 15 - HeX Group<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hex-group.eu\/nl_BE\/de-herziening-van-bijlage-15\/\" \/>\n<meta property=\"og:locale\" content=\"nl_BE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"De herziening van bijlage 15 - HeX Group\" \/>\n<meta property=\"og:description\" content=\"openbare raadpleging over kwalificatie en validatie Opmerkingen over het ontwerp worden aanvaard tot 31 mei 2014. 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