{"id":2182,"date":"2015-05-11T16:49:40","date_gmt":"2015-05-11T15:49:40","guid":{"rendered":"http:\/\/www.hygiene-expertise.com\/?p=2182"},"modified":"2015-05-11T16:49:40","modified_gmt":"2015-05-11T15:49:40","slug":"de-eca-becommentarieert-het-project-voor-de-herziening-van-bijlage-1","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/nl_BE\/de-eca-becommentarieert-het-project-voor-de-herziening-van-bijlage-1\/","title":{"rendered":"De ECA becommentarieert het project voor de herziening van Bijlage 1"},"content":{"rendered":"<p>| 5 mei 2015\u00a0|<\/p>\n<h2>De ECA-stichting reageert op de \u2018concept paper\u2019 die in februari jongstleden de herziening van Bijlage 1 van de Europese GMP inluidde.<\/h2>\n<a href=\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg\"><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-2174\" src=\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg\" alt=\"fondation ECA\" width=\"650\" height=\"432\" \/><\/a>\n<p>De termijn waarover de sector en de vertegenwoordigers ervan beschikten om commentaar te leveren op de concept paper en de herziening van Aanhangsel 1 van de <strong>Europese GMP<\/strong> was zeer kort: van februari (publicatie van het werkdocument) tot eind maart 2015. De <strong>ECA-stichting<\/strong> en haar belangengroep, de Europese vereniging van gekwalificeerde personen (EQPA), zijn er desondanks in geslaagd hun reacties tijdig te bundelen. De aan de EMA gerichte opmerkingen zijn over het algemeen positief en nemen deels de argumenten uit de concept paper over. Er wordt gevraagd om de nieuwe technologie\u00ebn die zich sinds 2008 aanzienlijk hebben ontwikkeld, zoals RABS die een precieze definitie vereisen, in de tekst op te nemen. Daarnaast verzoeken ze om meer informatie ten aanzien van luchtsluizen, evenals de toevoeging van twee nieuwe klassen E en F.<\/p>\n<p>Het is niet verrassend dat de <strong>ECA-EQPA<\/strong> een harmonisatie van Aanhangsel 1 met de huidige normen suggereert, namelijk met de vereisten van <strong>ISO 14644-1<\/strong> en in het bijzonder met die ten aanzien van het toezicht op partikels groter dan of gelijk aan 0,5 \u00b5m. Ook wordt gevraagd zich te conformeren aan ISO 5 voor de partikelgrens van 5 \u00b5m (29 deeltjes\/m3). Tegelijk oppert de deskundigengroep een harmonisering met de aseptische gids van de FDA.<br \/>\nNodig geachte preciseringen: de uitdrukking \u2018Grade A air supply\u2019 (\u2018luchtstroom van klasse A\u2019) die nog steeds niet werd verhelderd voor het felsen van capsules, hoewel dit punt al uitgebreid is besproken. Alle opmerkingen zullen spoedig worden gepubliceerd op de website van de ECA. De eerste herziening van Aanhangsel 1 zou ten vroegste in de loop van oktober worden vrijgegeven.<\/p>\n<p><em>Bron\u00a0:<\/em> <a href=\"http:\/\/processpropre.fr\/Actualites\/Reglementation\/Fiche\/1762\/L%2592ECA-commente-le-projet-de-revision-de-l-Annexe-1\" target=\"_blank\">processpropre.fr<\/a><\/p>\n<p><em>Lees ook\u00a0:<\/em>\u00a0<a title=\"De herziening van bijlage 15\" href=\"http:\/\/www.hygiene-expertise.com\/nl_BE\/de-herziening-van-bijlage-15\/\">De herziening van bijlage 15<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>| 5 mei 2015\u00a0| De ECA-stichting reageert op de \u2018concept paper\u2019 die in februari jongstleden de herziening van Bijlage 1 van de Europese GMP inluidde. De termijn waarover de sector en de vertegenwoordigers ervan beschikten om commentaar te leveren op de concept paper en de herziening van Aanhangsel 1 van de Europese GMP was zeer&#8230;  <a class=\"excerpt-read-more\" href=\"https:\/\/www.hex-group.eu\/nl_BE\/de-eca-becommentarieert-het-project-voor-de-herziening-van-bijlage-1\/\" title=\"Read De ECA becommentarieert het project voor de herziening van Bijlage 1\">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":[45],"tags":[],"class_list":["post-2182","post","type-post","status-publish","format-standard","hentry","category-regelgeving"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>De ECA becommentarieert het project voor de herziening van Bijlage 1 - 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-eca-becommentarieert-het-project-voor-de-herziening-van-bijlage-1\/\" \/>\n<meta property=\"og:locale\" content=\"nl_BE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"De ECA becommentarieert het project voor de herziening van Bijlage 1 - HeX Group\" \/>\n<meta property=\"og:description\" content=\"| 5 mei 2015\u00a0| De ECA-stichting reageert op de \u2018concept paper\u2019 die in februari jongstleden de herziening van Bijlage 1 van de Europese GMP inluidde. De termijn waarover de sector en de vertegenwoordigers ervan beschikten om commentaar te leveren op de concept paper en de herziening van Aanhangsel 1 van de Europese GMP was zeer... 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