{"id":1611,"date":"2014-02-13T22:44:06","date_gmt":"2014-02-13T21:44:06","guid":{"rendered":"http:\/\/www.hygiene-expertise.com\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel-2\/"},"modified":"2014-02-13T22:44:06","modified_gmt":"2014-02-13T21:44:06","slug":"review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/","title":{"rendered":"Review of chapter 2 of the GMP (part 1) relating to personnel"},"content":{"rendered":"<p>The changes are designed to incorporate the quality principles described in ICH Q10<\/p>\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>The deadline for the new <a href=\"http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-4\/2013-01-18_chapter2_.pdf\" target=\"_blank\"><span style=\"text-decoration: underline;\">review of chapter 2 of part of the European Good Manufacturing Practices Guide<\/span><\/a>\u00a0(EU GMP) relating to <b>personnel<\/b> to come into force is 16 February. The changes need to incorporate the principles of the \u201c<b>pharmaceutical quality system<\/b>\u201d as described in <a href=\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/ICH-Q10_Mai2013.pdf\" target=\"_blank\">ICH Q10<\/a>.<i>\u00a0\u201cThere must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer<\/i>\u201d, explains the \u201cPrinciple\u201d paragraph of chapter 2<i>.<\/i> \u201c<i>Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of <b>Good Manufacturing Practice<\/b>\u00a0that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.<\/i>\u201d\u00a0A section about <b>consultants<\/b>\u00a0has been added, complementing the sections relating to <b>key personnel<\/b>, <b>training<\/b>, and <b>personnel hygiene<\/b>.<i><\/i><\/p>\n<p>Source: <a href=\"http:\/\/www.processpropre.fr\" target=\"_blank\">www.processpropre.fr<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The changes are designed to incorporate the quality principles described in ICH Q10 The deadline for the new review of chapter 2 of part of the European Good Manufacturing Practices Guide\u00a0(EU GMP) relating to personnel to come into force is 16 February. The changes need to incorporate the principles of the \u201cpharmaceutical quality system\u201d as&#8230;  <a class=\"excerpt-read-more\" href=\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/\" title=\"Read Review of chapter 2 of the GMP (part 1) relating to personnel\">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-1611","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>Review of chapter 2 of the GMP (part 1) relating to personnel - 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\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Review of chapter 2 of the GMP (part 1) relating to personnel - HeX Group\" \/>\n<meta property=\"og:description\" content=\"The changes are designed to incorporate the quality principles described in ICH Q10 The deadline for the new review of chapter 2 of part of the European Good Manufacturing Practices Guide\u00a0(EU GMP) relating to personnel to come into force is 16 February. The changes need to incorporate the principles of the \u201cpharmaceutical quality system\u201d as... Read more &raquo;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/\" \/>\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=\"2014-02-13T21:44:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2014\/02\/20140213-actu.png\" \/>\n\t<meta property=\"og:image:width\" content=\"412\" \/>\n\t<meta property=\"og:image:height\" content=\"309\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/\"},\"author\":{\"name\":\"Justine Dubois\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/person\/7235bd5ccd4ee2272d199123391c4e3c\"},\"headline\":\"Review of chapter 2 of the GMP (part 1) relating to personnel\",\"datePublished\":\"2014-02-13T21:44:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/\"},\"wordCount\":162,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png\",\"inLanguage\":\"en-BE\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/\",\"url\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/\",\"name\":\"Review of chapter 2 of the GMP (part 1) relating to personnel - HeX Group\",\"isPartOf\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png\",\"datePublished\":\"2014-02-13T21:44:06+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#breadcrumb\"},\"inLanguage\":\"en-BE\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-BE\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#primaryimage\",\"url\":\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png\",\"contentUrl\":\"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/www.hex-group.eu\/en_BE\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Review of chapter 2 of the GMP (part 1) relating to personnel\"}]},{\"@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":"Review of chapter 2 of the GMP (part 1) relating to personnel - 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\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/","og_locale":"en_US","og_type":"article","og_title":"Review of chapter 2 of the GMP (part 1) relating to personnel - HeX Group","og_description":"The changes are designed to incorporate the quality principles described in ICH Q10 The deadline for the new review of chapter 2 of part of the European Good Manufacturing Practices Guide\u00a0(EU GMP) relating to personnel to come into force is 16 February. The changes need to incorporate the principles of the \u201cpharmaceutical quality system\u201d as... Read more &raquo;","og_url":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/","og_site_name":"HeX Group","article_publisher":"https:\/\/www.facebook.com\/hexgroupexpert\/","article_published_time":"2014-02-13T21:44:06+00:00","og_image":[{"width":412,"height":309,"url":"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2014\/02\/20140213-actu.png","type":"image\/png"}],"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\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#article","isPartOf":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/"},"author":{"name":"Justine Dubois","@id":"https:\/\/www.hex-group.eu\/en_BE\/#\/schema\/person\/7235bd5ccd4ee2272d199123391c4e3c"},"headline":"Review of chapter 2 of the GMP (part 1) relating to personnel","datePublished":"2014-02-13T21:44:06+00:00","mainEntityOfPage":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/"},"wordCount":162,"commentCount":0,"publisher":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/#organization"},"image":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#primaryimage"},"thumbnailUrl":"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png","inLanguage":"en-BE","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/","url":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/","name":"Review of chapter 2 of the GMP (part 1) relating to personnel - HeX Group","isPartOf":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#primaryimage"},"image":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#primaryimage"},"thumbnailUrl":"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png","datePublished":"2014-02-13T21:44:06+00:00","breadcrumb":{"@id":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#breadcrumb"},"inLanguage":"en-BE","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/"]}]},{"@type":"ImageObject","inLanguage":"en-BE","@id":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#primaryimage","url":"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png","contentUrl":"http:\/\/www.hygiene-expertise.com\/wp-content\/uploads\/2014\/02\/20140213-actu.png"},{"@type":"BreadcrumbList","@id":"https:\/\/www.hex-group.eu\/en_BE\/review-of-chapter-2-of-the-gmp-part-1-relating-to-personnel\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/www.hex-group.eu\/en_BE\/"},{"@type":"ListItem","position":2,"name":"Review of chapter 2 of the GMP (part 1) relating to personnel"}]},{"@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\/1611","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=1611"}],"version-history":[{"count":0,"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/posts\/1611\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/media?parent=1611"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/categories?post=1611"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hex-group.eu\/en_BE\/wp-json\/wp\/v2\/tags?post=1611"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}