{"id":6260,"date":"2021-02-24T17:02:39","date_gmt":"2021-02-24T17:02:39","guid":{"rendered":"http:\/\/164.90.225.225\/2023\/05\/02\/nitrosamine-impurities-have-lessons-been-learnt\/"},"modified":"2023-05-25T11:04:48","modified_gmt":"2023-05-25T10:04:48","slug":"nitrosamine-impurities-have-lessons-been-learnt","status":"publish","type":"post","link":"https:\/\/www.quinta.cz\/cs\/2021\/02\/24\/nitrosamine-impurities-have-lessons-been-learnt\/","title":{"rendered":"Nitrosamine Impurities – Have lessons been learnt?"},"content":{"rendered":"

Last week saw the publication of the European Medicines Agency report detailing what lessons can be learnt from the cases of unexpected N-nitrosamine impurities in sartans, which came to light mid-2018.<\/p>\n

\u200d<\/p>\n

\n
<\/div>\n<\/figure>\n

\u200d<\/p>\n

The 98-page report (found in full here: https:\/\/bit.ly\/2NJ4Pgl ) aims to prevent future cases by clarifying the roles and responsibilities of both the regulators and companies involved in the manufacture of medicines.<\/p>\n

By amending guidance on the control of impurities, the EMA are taking a proactive approach to reduce the risk of similar situations occurring with other medicines, and should ensure that regulators are better prepared to manage cases of unexpected impurities in the future.<\/p>\n

The recommendations, which now apply to ALL medicines, include developing additional guidance on a number of items such as sampling and testing, as well as improving communication with patients and healthcare professionals, further developing IT systems and expanding cooperation with international partners.<\/p>\n

There has never been a more critical time to choose a pharma partner who is both well versed in the latest requirements and recommendations, and who is highly experienced in Nitrosamine testing.<\/p>\n","protected":false},"excerpt":{"rendered":"

Last week saw the publication of the European Medicines Agency report detailing what lessons can be learnt from the cases of unexpected N-nitrosamine impurities in sartans, which came to light mid-2018.<\/p>\n","protected":false},"author":6,"featured_media":6261,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-6260","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorised"],"_links":{"self":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/6260","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/comments?post=6260"}],"version-history":[{"count":4,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/6260\/revisions"}],"predecessor-version":[{"id":7621,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/6260\/revisions\/7621"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/media\/6261"}],"wp:attachment":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/media?parent=6260"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/categories?post=6260"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/tags?post=6260"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}