{"id":72585,"date":"2016-07-21T10:25:00","date_gmt":"2016-07-21T10:25:00","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=87198812a89c44bc82e1c3acb5dd6ea7"},"modified":"2018-04-09T08:50:48","modified_gmt":"2018-04-09T08:50:48","slug":"news-story-mhra-gxp-data-integrity-definitions-and-guidance-for-industry","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=72585","title":{"rendered":"News story: MHRA GxP Data Integrity Definitions and Guidance for Industry"},"content":{"rendered":"<p><em>Updated:<\/em> Updated to withdraw the consultation document.<\/p>\n<div class=\"govspeak\">\n<div class=\"call-to-action\">\n<p>Updated to withdraw the consultation document. <a href=\"https:\/\/www.gov.uk\/government\/publications\/guidance-on-gxp-data-integrity\">View the final Guidance on GxP data integrity.<\/a><\/p>\n<\/div>\n<p>This <span id=\"attachment_2639786\" class=\"attachment-inline\"><br \/>\n  <a href=\"\/government\/uploads\/system\/uploads\/attachment_data\/file\/697047\/Withdrawn_MHRA_GxP_Data_Integrity_Definitions_and_Guidance_for_Industry.pdf\">consultation document<\/a><br \/>\n  (<span class=\"type\"><abbr title=\"Portable Document Format\">PDF<\/abbr><\/span>, <span class=\"file-size\">599KB<\/span>, <span class=\"page-length\">14 pages<\/span>)<br \/>\n<\/span><br \/>\n provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.<\/p>\n<p>The guidance is intended to be a useful resource on the core elements of a compliant data governance system across all GxP sectors (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilance practice).<\/p>\n<p>It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of which have resulted in regulatory action.<\/p>\n<p>The document should be read in conjunction with the applicable regulations and the general guidance specific to each GxP.<\/p>\n<p>We welcome your comments via the <span id=\"attachment_2639785\" class=\"attachment-inline\"><br \/>\n  <a href=\"\/government\/uploads\/system\/uploads\/attachment_data\/file\/538879\/Comment_sheet.doc\">comment sheet<\/a><br \/>\n  (<span class=\"type\">MS Word Document<\/span>, <span class=\"file-size\">224KB<\/span>)<br \/>\n<\/span><br \/>\n which can be emailed to <a href=\"mailto:inspectorate@mhra.gov.uk\">inspectorate@mhra.gov.uk<\/a><\/p>\n<p>Deadline for comments: 31 October 2016<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"_links":{"self":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/72585"}],"collection":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=72585"}],"version-history":[{"count":3,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/72585\/revisions"}],"predecessor-version":[{"id":90803,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/72585\/revisions\/90803"}],"wp:attachment":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=72585"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=72585"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=72585"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}