{"id":169,"date":"2019-10-09T17:57:42","date_gmt":"2019-10-09T14:57:42","guid":{"rendered":"http:\/\/cratia.com\/?p=169"},"modified":"2020-11-18T16:24:43","modified_gmt":"2020-11-18T14:24:43","slug":"upravlenie-kachestvom-gmp-gdp-gvp","status":"publish","type":"post","link":"https:\/\/cratia.com\/en\/uslugi\/lekarstvennye-sredstva\/upravlenie-kachestvom-gmp-gdp-gvp\/","title":{"rendered":"Quality: GMP, GDP, GVP"},"content":{"rendered":"<p><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">For more than 10 years we are assisting national and international companies on issues related to quality management systems of the manufacturer (GMP), import licensing and distribution (GDP) and pharmacovigilance (GVP).<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">We use the services of our own employees or involve external experts with relevant work experience and technical knowledge. We have deep knowledge of the national and international legislation, have extensive experience and are responsible for the result.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">We are ready to perform the following works:<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><b>I. <\/b>\u00a0<\/span><b>GMP inspections:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">In-depth analysis of SMF, preparation of recommendations;\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Independent on-site pre-audit;\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Staff training;\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Support during the inspection process by the competent authority;\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">CAPA.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\"><b>II. <\/b>\u00a0<\/span><b>Site establishment:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Consulting at the planning stage;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Design, qualification of the project or it\u2019s parts;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Qualification of technological and laboratory equipment (IQ, OQ, PQ);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Qualification of clean premises and engineering systems;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of a Validation master plan;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of Master Batch Records (MBR);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Validation of the process;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of SOP;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of SMF;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Staff training;<\/span><\/li>\n<\/ul>\n<p><b>III. Import licensing and distribution (GDP)<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Independent audit of the importer, distributor;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Consulting at the stage of warehouse planning;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of SOP;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of Master File;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Staff training;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Support during the inspection process by the competent authority;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">CAPA.<\/span><\/li>\n<\/ul>\n<p><b>IV. Pharmacovigilance (GVP):<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Independent audit of the pharmacovigilance system of a representative office, service provider or manufacturer;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of SOP;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Development of PV Master File;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Staff training.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Cratia provides professional services related to quality management systems in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Uzbekistan, Ukraine and the Eurasian Economic Union. We are well versed in the national legislation, we have the necessary experience and resources to carry out the work.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: <a href=\"mailto:info@cratia.ua\">info@cratia.ua<\/a>, or visit <a href=\"\/en\/contacts\/\">our office<\/a>.\u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>For more than 10 years we are assisting national and international companies on issues related to quality management systems of the manufacturer (GMP), import licensing and distribution (GDP) and pharmacovigilance (GVP). We use the services of our own employees or involve external experts with relevant work experience and technical knowledge. We have deep knowledge of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12,20],"tags":[],"class_list":["post-169","post","type-post","status-publish","format-standard","hentry","category-lekarstvennye-sredstva","category-uslugi"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/posts\/169","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/comments?post=169"}],"version-history":[{"count":12,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/posts\/169\/revisions"}],"predecessor-version":[{"id":1886,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/posts\/169\/revisions\/1886"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=169"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/categories?post=169"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/tags?post=169"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}