{"id":2184,"date":"2015-05-11T16:55:28","date_gmt":"2015-05-11T15:55:28","guid":{"rendered":"http:\/\/www.hygiene-expertise.com\/?p=2184"},"modified":"2015-05-11T16:56:50","modified_gmt":"2015-05-11T15:56:50","slug":"the-eca-comments-on-the-draft-revision-of-annex-1","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/","title":{"rendered":"The ECA comments on the draft revision of Annex 1"},"content":{"rendered":"

| 5 May\u00a02015\u00a0|<\/p>\n

The ECA Foundation reacts to the concept paper that confirmed the revision of Annex 1 of the European GMP last February.<\/h2>\n\"fondation<\/a>\n

The industry and its representatives were not given much time to comment on the concept paper on the revision of Annex 1 of the European GMP<\/strong>: from February (when the working document was published) until the end of March 2015. The ECA Foundation and its interest group, the Association des Personnes Qualifi\u00e9es en Europe (association of qualified people in Europe or EQPA) did however manage to put together their feedback within the deadline. The comments submitted to the EMA were generally positive and in part covered the arguments in the concept paper. They asked for the incorporation of new technologies in the text that have been developed significantly since 2008, such as RABS, which need a clear definition. More details about airlocks were also requested, along with the addition of two new categories, E and F.
\nUnsurprisingly, the ECA-EQPA<\/strong> suggested bringing Annex 1 into line with current standards, including ISO 14644-1<\/strong> requirements and in particular those related to monitoring particulates with a diameter greater than or equal to 0.5\u00b5m. There was also a request to come into line with ISO 5 for a particle limit of 5 \u00b5m (29 part\/m3). Alongside this, the group of experts suggested bringing the document into line with the FDA\u2019s aseptic guide.
\nSome of the clarifications deemed necessary were: the expression \u201cGrade A air supply\u201d, which has still not been clarified for sealing caps, even though this point was discussed extensively. All of the comments will soon be published on the ECA\u2019s website. The first draft of Annex 1 is due to be released in October at the soonest.<\/p>\n

Source\u00a0:<\/em> processpropre.fr<\/a><\/p>\n

Also read\u00a0:<\/em>\u00a0The revision of Annex 15<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

| 5 May\u00a02015\u00a0| The ECA Foundation reacts to the concept paper that confirmed the revision of Annex 1 of the European GMP last February. The industry and its representatives were not given much time to comment on the concept paper on the revision of Annex 1 of the European GMP: from February (when the working… 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":[46],"tags":[],"class_list":["post-2184","post","type-post","status-publish","format-standard","hentry","category-regulations"],"acf":[],"yoast_head":"\nThe ECA comments on the draft revision of Annex 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\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The ECA comments on the draft revision of Annex 1 - HeX Group\" \/>\n<meta property=\"og:description\" content=\"| 5 May\u00a02015\u00a0| The ECA Foundation reacts to the concept paper that confirmed the revision of Annex 1 of the European GMP last February. The industry and its representatives were not given much time to comment on the concept paper on the revision of Annex 1 of the European GMP: from February (when the working... Read more »\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/\" \/>\n<meta property=\"og:site_name\" content=\"HeX Group\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/hexgroupexpert\/\" \/>\n<meta property=\"article:published_time\" content=\"2015-05-11T15:55:28+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2015-05-11T15:56:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"650\" \/>\n\t<meta property=\"og:image:height\" content=\"432\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Justine Dubois\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Justine Dubois\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/\"},\"author\":{\"name\":\"Justine Dubois\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/person\/7235bd5ccd4ee2272d199123391c4e3c\"},\"headline\":\"The ECA comments on the draft revision of Annex 1\",\"datePublished\":\"2015-05-11T15:55:28+00:00\",\"dateModified\":\"2015-05-11T15:56:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/\"},\"wordCount\":299,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg\",\"articleSection\":[\"Regulations\"],\"inLanguage\":\"en-BE\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/\",\"url\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/\",\"name\":\"The ECA comments on the draft revision of Annex 1 - HeX Group\",\"isPartOf\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg\",\"datePublished\":\"2015-05-11T15:55:28+00:00\",\"dateModified\":\"2015-05-11T15:56:50+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#breadcrumb\"},\"inLanguage\":\"en-BE\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-BE\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#primaryimage\",\"url\":\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg\",\"contentUrl\":\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/www.hex-group.eu\/en_BE\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"The ECA comments on the draft revision of Annex 1\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#website\",\"url\":\"https:\/\/www.hex-group.eu\/en_BE\/\",\"name\":\"HeX Group\",\"description\":\"Your expert in contamination control\",\"publisher\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.hex-group.eu\/en_BE\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-BE\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#organization\",\"name\":\"HeX Group\",\"url\":\"https:\/\/www.hex-group.eu\/en_BE\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-BE\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2023\/08\/Xquadri-PNG.png\",\"contentUrl\":\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2023\/08\/Xquadri-PNG.png\",\"width\":1431,\"height\":1353,\"caption\":\"HeX Group\"},\"image\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/hexgroupexpert\/\",\"https:\/\/www.linkedin.com\/company\/3159622\/\",\"https:\/\/www.youtube.com\/@hexgroup-yourexpertinconta8582\/videos\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/person\/7235bd5ccd4ee2272d199123391c4e3c\",\"name\":\"Justine Dubois\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-BE\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/a3e8357c2801d913e5a555e0524180e15983979de06c92d4cadb7ec607f6420e?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/a3e8357c2801d913e5a555e0524180e15983979de06c92d4cadb7ec607f6420e?s=96&d=mm&r=g\",\"caption\":\"Justine Dubois\"},\"url\":\"https:\/\/www.hex-group.eu\/en_BE\/author\/justine-dubois\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"The ECA comments on the draft revision of Annex 1 - HeX Group","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/","og_locale":"en_US","og_type":"article","og_title":"The ECA comments on the draft revision of Annex 1 - HeX Group","og_description":"| 5 May\u00a02015\u00a0| The ECA Foundation reacts to the concept paper that confirmed the revision of Annex 1 of the European GMP last February. The industry and its representatives were not given much time to comment on the concept paper on the revision of Annex 1 of the European GMP: from February (when the working... Read more »","og_url":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/","og_site_name":"HeX Group","article_publisher":"https:\/\/www.facebook.com\/hexgroupexpert\/","article_published_time":"2015-05-11T15:55:28+00:00","article_modified_time":"2015-05-11T15:56:50+00:00","og_image":[{"width":650,"height":432,"url":"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg","type":"image\/jpeg"}],"author":"Justine Dubois","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Justine Dubois","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#article","isPartOf":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/"},"author":{"name":"Justine Dubois","@id":"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/person\/7235bd5ccd4ee2272d199123391c4e3c"},"headline":"The ECA comments on the draft revision of Annex 1","datePublished":"2015-05-11T15:55:28+00:00","dateModified":"2015-05-11T15:56:50+00:00","mainEntityOfPage":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/"},"wordCount":299,"commentCount":0,"publisher":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/#organization"},"image":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#primaryimage"},"thumbnailUrl":"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg","articleSection":["Regulations"],"inLanguage":"en-BE","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/","url":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/","name":"The ECA comments on the draft revision of Annex 1 - HeX Group","isPartOf":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#primaryimage"},"image":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#primaryimage"},"thumbnailUrl":"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg","datePublished":"2015-05-11T15:55:28+00:00","dateModified":"2015-05-11T15:56:50+00:00","breadcrumb":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#breadcrumb"},"inLanguage":"en-BE","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/"]}]},{"@type":"ImageObject","inLanguage":"en-BE","@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#primaryimage","url":"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg","contentUrl":"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2015\/05\/ecarevision-annexe-1.jpg"},{"@type":"BreadcrumbList","@id":"https:\/\/www.hex-group.eu\/en_BE\/the-eca-comments-on-the-draft-revision-of-annex-1\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/www.hex-group.eu\/en_BE\/"},{"@type":"ListItem","position":2,"name":"The ECA comments on the draft revision of Annex 1"}]},{"@type":"WebSite","@id":"https:\/\/www.hex-group.eu\/en_BE\/#website","url":"https:\/\/www.hex-group.eu\/en_BE\/","name":"HeX Group","description":"Your expert in contamination control","publisher":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.hex-group.eu\/en_BE\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-BE"},{"@type":"Organization","@id":"https:\/\/www.hex-group.eu\/en_BE\/#organization","name":"HeX Group","url":"https:\/\/www.hex-group.eu\/en_BE\/","logo":{"@type":"ImageObject","inLanguage":"en-BE","@id":"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/logo\/image\/","url":"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2023\/08\/Xquadri-PNG.png","contentUrl":"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2023\/08\/Xquadri-PNG.png","width":1431,"height":1353,"caption":"HeX Group"},"image":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/hexgroupexpert\/","https:\/\/www.linkedin.com\/company\/3159622\/","https:\/\/www.youtube.com\/@hexgroup-yourexpertinconta8582\/videos"]},{"@type":"Person","@id":"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/person\/7235bd5ccd4ee2272d199123391c4e3c","name":"Justine Dubois","image":{"@type":"ImageObject","inLanguage":"en-BE","@id":"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/a3e8357c2801d913e5a555e0524180e15983979de06c92d4cadb7ec607f6420e?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/a3e8357c2801d913e5a555e0524180e15983979de06c92d4cadb7ec607f6420e?s=96&d=mm&r=g","caption":"Justine Dubois"},"url":"https:\/\/www.hex-group.eu\/en_BE\/author\/justine-dubois\/"}]}},"_links":{"self":[{"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/posts\/2184","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/users\/21"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/comments?post=2184"}],"version-history":[{"count":4,"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/posts\/2184\/revisions"}],"predecessor-version":[{"id":2188,"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/posts\/2184\/revisions\/2188"}],"wp:attachment":[{"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/media?parent=2184"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/categories?post=2184"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/tags?post=2184"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}