{"id":1640,"date":"2014-01-13T21:24:35","date_gmt":"2014-01-13T20:24:35","guid":{"rendered":"http:\/\/www.hygiene-expertise.com\/besmette-zakjes-2\/"},"modified":"2014-01-13T21:24:35","modified_gmt":"2014-01-13T20:24:35","slug":"besmette-zakjes","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/nl_BE\/besmette-zakjes\/","title":{"rendered":"Besmette zakjes"},"content":{"rendered":"<h2>Uit inspectie van het laboratorium blijkt non-conformiteit met de GMP<b><\/b><\/h2>\n<p>Bastien Cany | 9 januari 2014 |<\/p>\n<a href=\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/01\/hex-20140113-s.jpg\"><img fetchpriority=\"high\" decoding=\"async\" class=\"alignleft size-full wp-image-1286\" alt=\"Poches contamin\u00e9es \" src=\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/01\/hex-20140113-s.jpg\" width=\"319\" height=\"165\" \/><\/a>\n<p>Het laboratorium Marette is gelegen in de gebouwen van deze apotheek te Courseulles-sur-mer (c) Pyc.<\/p>\n<p>De beslissing met betrekking tot de veterinairrechtelijke voorschriften voor het laboratorium Marette vermeldt een aantal afwijkingen van de bepalingen van richtlijn 1 van de Good Manufacturing Practices voor de farmaceutische industrie.<\/p>\n<p>Na nieuw onderzoek begin deze week heeft het Franse nationale agentschap voor geneesmiddelen en gezondheidsproducten (Agence nationale de s\u00e9curit\u00e9 des produits pharmaceutiques &#8211; ANSM) eindelijk de activiteiten opgeschort voor bereidingen volgens recept en ziekenhuisbereidingen van het bedrijf Marette te Courseulles-sur-mer in Calvados. Deze beslissing is ook gebaseerd op de bevestiging van een bacteri\u00eble besmetting in de zakjes met sondevoeding die door het bedrijf geproduceerd werden en verantwoordelijk zouden zijn voor de dood van drie pasgeborenen in het ziekenhuis van Chamb\u00e9ry vorige maand. Het ANSM vermeldt voor het eerst duidelijk de niet-naleving van een aantal bepalingen van de Good Manufacturing Practices voor de farmaceutische industrie door het laboratorium.<\/p>\n<p><b>Deze afwijkingen betreffen voornamelijk richtlijn 1 van de GMP voor steriele geneesmiddelen.<\/b> In de tekst staat dat de onderneming &#8220;geen volledige beheersing van de besmettingsrisico&#8217;s voor hun productie waarborgt&#8221;. De inspecteurs hebben non-conformiteit vastgesteld voor de ontsmetting van de handen v\u00f3\u00f3r de bewerking, voor de controle van de handschoenen na kritieke bewerkingen, bij het beheer van milieugerelateerde anomalie\u00ebn en bij het binnen- en buitengaan van de gecontroleerde omgevingszone.<\/p>\n<p><b>Er werd echter geen enkel rechtstreeks verband vastgesteld tussen de afwijkingen en de oorzaken van de besmetting.<\/b> Er werd \u00e9\u00e9n enkele pathogeen gedetecteerd in de geanalyseerde zakjes. Het gaat om een nieuw soort enterobacterie die nog geen naam kreeg, maar verwant is met Ewingella en Rahnella. De resultaten wezen overigens op een bijzonder hoge endotoxische concentratie. Tot op heden hebben het Ministerie van Volksgezondheid en het ANSM geen nadere toelichtingen gegeven over de aard van de aseptische uitrusting die gebruikt werd door het bedrijf: cleanrooms, kiemvrije ruimten en microbiologische veiligheidskasten \u2026\u00a0Zolang de oorsprong van deze besmetting onbekend blijft, wordt er verder diepgaand onderzoek van de volledige productie- en toeleveringsketen uitgevoerd.<\/p>\n<p>Bron: <a title=\"Process Propre\" href=\"http:\/\/www.processpropre.fr\" target=\"_blank\">www.processpropre.fr<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Uit inspectie van het laboratorium blijkt non-conformiteit met de GMP Bastien Cany | 9 januari 2014 | Het laboratorium Marette is gelegen in de gebouwen van deze apotheek te Courseulles-sur-mer (c) Pyc. De beslissing met betrekking tot de veterinairrechtelijke voorschriften voor het laboratorium Marette vermeldt een aantal afwijkingen van de bepalingen van richtlijn 1 van&#8230;  <a class=\"excerpt-read-more\" href=\"https:\/\/www.hex-group.eu\/nl_BE\/besmette-zakjes\/\" title=\"Read Besmette zakjes\">Read more &raquo;<\/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-1640","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Besmette zakjes - 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\/besmette-zakjes\/\" \/>\n<meta property=\"og:locale\" content=\"nl_BE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Besmette zakjes - HeX Group\" \/>\n<meta property=\"og:description\" content=\"Uit inspectie van het laboratorium blijkt non-conformiteit met de GMP Bastien Cany | 9 januari 2014 | Het laboratorium Marette is gelegen in de gebouwen van deze apotheek te Courseulles-sur-mer (c) Pyc. 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