{"id":648,"date":"2013-10-16T09:38:15","date_gmt":"2013-10-16T07:38:15","guid":{"rendered":"https:\/\/dev.medizone.com\/?p=648"},"modified":"2016-01-21T19:58:16","modified_gmt":"2016-01-21T17:58:16","slug":"new-eu-gdp-guidelines-of-07-03-2013-update-08-09-2013","status":"publish","type":"post","link":"https:\/\/medizone.com\/en\/new-eu-gdp-guidelines-of-07-03-2013-update-08-09-2013\/","title":{"rendered":"New EU GDP Guidelines of 07.03.2013 &#8211; Update 08.09.2013"},"content":{"rendered":"<p>The \u201cGuidelines on Good Distribution Practice of Medicinal Products for Human Use\u201d have been published 07.03.2013 and will apply across the European Union as of 8 September 2013. With the project \u201cGDP-Readiness\u201d Medizone checked all SOP\u2019s and procedures to ensure full compliance to the new Version of the Guidelines. These are only some of the action items we performed in the last six months:<\/p>\n<ul>\n<li>All of our established and proven transport partners were re-qualified and Quality Agreements have been established, where they did not exist in the past.<\/li>\n<li>The preparation for more stringent rules on transport and temperature monitoring during transport has been finalized and implemented.<\/li>\n<li>The Cold-Chain-Procedures have been expanded to cover Controlled-Room-Temperature, too. SOP \u201cCold Chain\u201d got \u201cThermo-Sensitive Pharmaceuticals\u201d<\/li>\n<li>All SOP\u2019s have been reviewed to ensure full compliance to the new Version of the Guidelines.<\/li>\n<li>CAPA-procedures \u2013 as we still did in the past \u2013 have been described in the new SOP \u201cCAPA (Corrective And Preventive Action)\u201d<\/li>\n<li>Master Data Procedures \u2013 that we still handled according to the four-eye-principle in the past \u2013 have been described in the new SOP \u201cMaster Data\u201d.<\/li>\n<\/ul>\n<p>To be continued\u2026 With our procedures we try to get even better day by day to<\/p>\n<p>provide better service to our clients.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The \u201cGuidelines on Good Distribution Practice of Medicinal Products for Human Use\u201d have been published 07.03.2013 and will apply across the European Union as of 8 September 2013. With the project \u201cGDP-Readiness\u201d Medizone checked all SOP\u2019s and procedures to ensure full compliance to the new Version of the Guidelines. These are only some of the [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[12],"tags":[],"class_list":["post-648","post","type-post","status-publish","format-standard","hentry","category-allgemein-2"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/648","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/comments?post=648"}],"version-history":[{"count":11,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/648\/revisions"}],"predecessor-version":[{"id":1217,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/648\/revisions\/1217"}],"wp:attachment":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/media?parent=648"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/categories?post=648"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/tags?post=648"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}