{"id":1635,"date":"2014-05-09T11:29:47","date_gmt":"2014-05-09T10:29:47","guid":{"rendered":"http:\/\/www.hygiene-expertise.com\/de-herziening-van-hoofdstuk-6-van-de-gmp-2\/"},"modified":"2018-03-06T11:55:26","modified_gmt":"2018-03-06T10:55:26","slug":"de-herziening-van-hoofdstuk-6-van-de-gmp","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/nl_BE\/de-herziening-van-hoofdstuk-6-van-de-gmp\/","title":{"rendered":"De herziening van hoofdstuk 6 van de GMP"},"content":{"rendered":"

\u00a0<\/span><\/span>Lucile Roger Durieux | 28 april 2014 |<\/p>\n

Hoofdstuk 6 (deel 1) van de GMP integreert de overdracht van testmethodes<\/h2>\n

De herziening van hoofdstuk 6 van de GMP\u00a0: Kwaliteitscontrole van de Europese richtlijn zal in het najaar in werking treden.<\/p>\n

De Europese Commissie heeft een herziening aangekondigd van hoofdstuk 6<\/a> : Kwaliteitscontrole van de Europese richtlijn inzake goede praktijken bij het farmaceutische vervaardigingsproces<\/strong> (EU-richtlijn voor goede praktijken bij de vervaardiging van geneesmiddelen voor menselijk en diergeneeskundig gebruik<\/em>, deel 1).<\/p>\n

Overdracht van \u00e9\u00e9n laboratorium naar een ander<\/strong><\/h2>\n

De wijziging bestaat uit het integreren van een onderdeel met betrekking tot technieken voor de overdracht van testmethodes<\/b> (en andere elementen zoals buiten de specificaties vallende resultaten). Dit nieuwe onderdeel bevat met name raadgevingen betreffende de overdracht van \u00e9\u00e9n laboratorium naar een ander en het overdrachtsprotocol (identificering van de uit te voeren tests, te testen monsters, enz.).\u00a0Het is eveneens een aanvulling van de paragrafen over de goede laboratoriumpraktijken<\/b> inzake kwaliteitscontrole<\/b> (documentatie, monsterneming, opvolging van de stabiliteit \u2026).<\/p>\n

De uiterste datum voor de inwerkingtreding van deze nieuwe versie van de tekst werd vastgelegd op 1 oktober 2014.<\/p>\n

Source\u00a0:<\/em> www.processpropre.fr<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\u00a0Lucile Roger Durieux | 28 april 2014 | Hoofdstuk 6 (deel 1) van de GMP integreert de overdracht van testmethodes De herziening van hoofdstuk 6 van de GMP\u00a0: Kwaliteitscontrole van de Europese richtlijn zal in het najaar in werking treden. De Europese Commissie heeft een herziening aangekondigd van hoofdstuk 6 : Kwaliteitscontrole van de Europese… 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-1635","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"yoast_head":"\nDe herziening van hoofdstuk 6 van de GMP - HeX Group<\/title>\n<meta name=\"description\" content=\"De herziening van hoofdstuk 6 van de GMP : Kwaliteitscontrole van de Europese richtlijn zal in het najaar in werking treden.\" \/>\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-hoofdstuk-6-van-de-gmp\/\" \/>\n<meta property=\"og:locale\" content=\"nl_BE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"De herziening van hoofdstuk 6 van de GMP - 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