{"id":137,"date":"2019-01-14T17:41:45","date_gmt":"2019-01-14T21:41:45","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=137"},"modified":"2019-01-14T17:41:45","modified_gmt":"2019-01-14T21:41:45","slug":"fda-issues-final-guidance-on-data-integrity-and-compliance-with-drug-cgmp","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/01\/14\/fda-issues-final-guidance-on-data-integrity-and-compliance-with-drug-cgmp\/","title":{"rendered":"FDA Issues Final Guidance on Data Integrity and Compliance with Drug CGMP"},"content":{"rendered":"<p>Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate. The Food and Drug Administration (FDA) considers data integrity to be critical throughout the current good manufacturing practice (CGMP) to ensure product quality and public safety. In response to an increased number of data integrity violations, which have led to warning letters, import alerts and consent decrees, the FDA published a draft guidance on Data Integrity and Compliance with CGMP on April 14, 2016. After considering comments to the draft guidance, the FDA has now issued its Final Guidance on\u00a0<a title=\"FDA Guidance: Data Integrity and Compliance with Drug CGMP\" href=\"https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM495891.pdf\" target=\"_blank\" rel=\"noopener\">Data Integrity and Compliance with Drug CGMP<\/a>\u00a0on December 12, 2018. The Final Guidance is in a Q&amp;A format and provides detailed instructions to the industry that reflects the FDA\u2019s current\u00a0thinking on data integrity.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_issues_final_guidance_data_integrity_compliance_cgmp_0119.html\">Read the full Duane Morris <em>Alert<\/em><\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate. The Food and Drug Administration (FDA) considers data integrity to be critical throughout the current good manufacturing practice (CGMP) to ensure product &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/01\/14\/fda-issues-final-guidance-on-data-integrity-and-compliance-with-drug-cgmp\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Issues Final Guidance on Data Integrity and Compliance with Drug CGMP&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[342,343,344,29,65,209,323,332,77,345,119],"ppma_author":[521],"class_list":["post-137","post","type-post","status-publish","format-standard","hentry","category-general","tag-cgmp","tag-data","tag-data-integrity","tag-fda","tag-final-guidance","tag-frederick-ball","tag-medical-devices","tag-moreshwar-vaze","tag-pharmaceutical","tag-qa","tag-rick-ball"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/137","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=137"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/137\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=137"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=137"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=137"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=137"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}