{"id":3,"date":"2024-04-04T00:36:58","date_gmt":"2024-04-03T21:36:58","guid":{"rendered":"https:\/\/sisu.ut.ee\/valchrom\/guides\/"},"modified":"2024-07-01T09:17:57","modified_gmt":"2024-07-01T06:17:57","slug":"guides","status":"publish","type":"page","link":"https:\/\/sisu.ut.ee\/valchrom\/guides\/","title":{"rendered":"Guides"},"content":{"rendered":"<p>Different organizations have composed their own guidelines about validation of single laboratory analytical methods. The most important validation guides are listed below.<\/p>\n<p><strong>Implemented in VaLChrom (partially\/fully):<\/strong><\/p>\n<ul>\n<li><a title=\"Eurachem\" href=\"https:\/\/www.eurachem.org\/images\/stories\/Guides\/pdf\/MV_guide_2nd_ed_EN.pdf\" target=\"_blank\" rel=\"noopener\">Eurachem <\/a>analytical method validation<\/li>\n<li><a title=\"ICH\" href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf\" target=\"_blank\" rel=\"noopener\" data-url=\" https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf\">ICH (International Conference on Harmonization) <\/a>validation study requirements for tests used to support drug approval submission<\/li>\n<li>EMA (European Medicines Agency) bioanalytical method validation<\/li>\n<\/ul>\n<p><strong>Planned to be implemented:<\/strong><\/p>\n<ul>\n<li><a title=\"IUPAC\" href=\"http:\/\/www.iupac.org\/publications\/pac\/2002\/pdf\/7405x0835.pdf\" target=\"_blank\" rel=\"noopener\">IUPAC (International Union of Pure and Applied Chemistry) <\/a>single-laboratory validation of analytical methods<\/li>\n<li>AOAC International single-laboratory validation of analytical methods<\/li>\n<li><a href=\"https:\/\/www.fda.gov\/files\/drugs\/published\/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf\" target=\"_blank\" rel=\"noopener\">FDA (The United States Food and Drug Administration)<\/a> bioanalytical method validation<\/li>\n<li><a href=\"https:\/\/www.nmkl.org\/wp-content\/uploads\/2022\/06\/NordVal-protocol-No-2_Chem_Oct-2018-1.pdf\" target=\"_blank\" rel=\"noopener\">NordVal<\/a> validation of proprietary chemical methods (test kits)<\/li>\n<li><a href=\"https:\/\/www.eurl-pesticides.eu\/\/docs\/public\/tmplt_article.asp?CntID=727&amp;LabID=100&amp;Lang=EN\" target=\"_blank\" rel=\"noopener\">SANTE\/11813\/2017:<\/a>\u00a0Guidance document on analytical quality control and method validation procedures for pesticide residues and analysis in food and feed<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Different organizations have composed their own guidelines about validation of single laboratory analytical methods. The most important validation guides are listed below. Implemented in VaLChrom (partially\/fully): Eurachem analytical method validation ICH (International Conference on Harmonization) validation study requirements for tests &#8230;<\/p>\n","protected":false},"author":57,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-3","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/sisu.ut.ee\/valchrom\/wp-json\/wp\/v2\/pages\/3","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sisu.ut.ee\/valchrom\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sisu.ut.ee\/valchrom\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sisu.ut.ee\/valchrom\/wp-json\/wp\/v2\/users\/57"}],"replies":[{"embeddable":true,"href":"https:\/\/sisu.ut.ee\/valchrom\/wp-json\/wp\/v2\/comments?post=3"}],"version-history":[{"count":6,"href":"https:\/\/sisu.ut.ee\/valchrom\/wp-json\/wp\/v2\/pages\/3\/revisions"}],"predecessor-version":[{"id":82,"href":"https:\/\/sisu.ut.ee\/valchrom\/wp-json\/wp\/v2\/pages\/3\/revisions\/82"}],"wp:attachment":[{"href":"https:\/\/sisu.ut.ee\/valchrom\/wp-json\/wp\/v2\/media?parent=3"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}