{"id":1639,"date":"2014-02-13T22:40:29","date_gmt":"2014-02-13T21:40:29","guid":{"rendered":"http:\/\/www.hygiene-expertise.com\/herziening-van-hoofdstuk-2-van-de-gmp-deel-1-betreffende-het-personeel-2\/"},"modified":"2014-02-13T22:40:29","modified_gmt":"2014-02-13T21:40:29","slug":"herziening-van-hoofdstuk-2-van-de-gmp-deel-1-betreffende-het-personeel","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/nl_BE\/herziening-van-hoofdstuk-2-van-de-gmp-deel-1-betreffende-het-personeel\/","title":{"rendered":"Herziening van hoofdstuk 2 van de GMP (deel 1) betreffende het personeel"},"content":{"rendered":"<h2>De wijzigingen hebben betrekking op de integratie van de kwaliteitsprincipes zoals beschreven in richtlijn ICH Q10<\/h2>\n<div id=\"attachment_1298\" style=\"width: 422px\" class=\"wp-caption alignleft\"><a href=\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png\"><img fetchpriority=\"high\" decoding=\"async\" aria-describedby=\"caption-attachment-1298\" class=\"size-full wp-image-1298\" alt=\"\u00a9 Entegris\" src=\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png\" width=\"412\" height=\"309\" \/><\/a><p id=\"caption-attachment-1298\" class=\"wp-caption-text\">\u00a9 Entegris<\/p><\/div>\n<p>De\u00a0<span style=\"text-decoration: underline;\"><a href=\"http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-4\/2013-01-18_chapter2_.pdf\" target=\"_blank\">herziening van hoofdstuk 2 van deel 1 van de Europese Gids inzake goede praktijken bij het vervaardigen van geneesmiddelen<\/a><\/span>\u00a0(EU GMP) betreffende het\u00a0<b>personeel<\/b>, treedt ten laatste op 16 februari in werking. De aangebrachte wijzigingen moeten ervoor zorgen dat de principes van het &#8220;<b>farmaceutische kwaliteitssysteem<\/b>&#8221; zoals beschreven in de richtlijn <a href=\"http:\/\/ansm.sante.fr\/content\/download\/48614\/625128\/version\/1\/file\/ICH-Q10_Mai2013.pdf\">ICH Q10<\/a>\u00a0ge\u00efntegreerd worden. <i>\u201cEr moet voldoende gekwalificeerd personeel zijn om alle taken waarvoor de fabrikant verantwoordelijk is tot een goed einde te brengen.\u201d<\/i>, preciseert de paragraaf &#8220;principe&#8221; in hoofdstuk 2.<i> \u201cDe individuen moeten hun individuele verantwoordelijkheden goed hebben begrepen en opgenomen. Ieder personeelslid moet op de hoogte zijn van de principes van de <b>Goede praktijken bij het vervaardigen van geneesmiddelen <\/b>die op hen van toepassing zijn en een basisopleiding en bij- en nascholing krijgen over de hygi\u00ebne-instructies afgestemd op hun behoeften.\u201d<\/i> Er is een sectie toegevoegd over de <b>consultants<\/b> waardoor de onderdelen betreffende <b>leidinggevend personeel, opleiding<\/b> en <b>personeelshygi\u00ebne <\/b>worden vervolledigd.<\/p>\n<p>Bron: <a href=\"http:\/\/www.processpropre.fr\/\" target=\"_blank\">www.processpropre.fr<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>De wijzigingen hebben betrekking op de integratie van de kwaliteitsprincipes zoals beschreven in richtlijn ICH Q10 De\u00a0herziening van hoofdstuk 2 van deel 1 van de Europese Gids inzake goede praktijken bij het vervaardigen van geneesmiddelen\u00a0(EU GMP) betreffende het\u00a0personeel, treedt ten laatste op 16 februari in werking. De aangebrachte wijzigingen moeten ervoor zorgen dat de principes&#8230;  <a class=\"excerpt-read-more\" href=\"https:\/\/www.hex-group.eu\/nl_BE\/herziening-van-hoofdstuk-2-van-de-gmp-deel-1-betreffende-het-personeel\/\" title=\"Read Herziening van hoofdstuk 2 van de GMP (deel 1) betreffende het personeel\">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-1639","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>Herziening van hoofdstuk 2 van de GMP (deel 1) betreffende het personeel - 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\/herziening-van-hoofdstuk-2-van-de-gmp-deel-1-betreffende-het-personeel\/\" \/>\n<meta property=\"og:locale\" content=\"nl_BE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Herziening van hoofdstuk 2 van de GMP (deel 1) betreffende het personeel - HeX Group\" \/>\n<meta property=\"og:description\" content=\"De wijzigingen hebben betrekking op de integratie van de kwaliteitsprincipes zoals beschreven in richtlijn ICH Q10 De\u00a0herziening van hoofdstuk 2 van deel 1 van de Europese Gids inzake goede praktijken bij het vervaardigen van geneesmiddelen\u00a0(EU GMP) betreffende het\u00a0personeel, treedt ten laatste op 16 februari in werking. 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