{"id":995,"date":"2025-10-21T17:44:30","date_gmt":"2025-10-21T15:44:30","guid":{"rendered":"https:\/\/www.supera-kvaliteta.hr\/medicinal-products\/"},"modified":"2025-12-24T15:29:15","modified_gmt":"2025-12-24T14:29:15","slug":"medicinal-products","status":"publish","type":"page","link":"https:\/\/www.supera-kvaliteta.hr\/en\/medicinal-products\/","title":{"rendered":"Medicinal products"},"content":{"rendered":"<section class=\"l-section wpb_row height_medium width_custom\" style=\"--site-content-width:1050px;\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\"><div class=\"wpb_column vc_column_container us_custom_af7e40fa has_bg_color\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column us_custom_432d3f53 h1-small\"><div class=\"wpb_wrapper\"><h1 style=\"text-align: center\">Medicinal products<\/h1>\n<div class=\"mod_tquote_quote\">\n<blockquote>\n<p><b>If you can\u2019t describe what you are doing as a process, you don\u2019t know what you\u2019re doing.&#8221;<\/b><span> <\/span>|<span> W. Edwards Deming<br \/><\/span><\/p>\n<\/blockquote>\n<\/div>\n<p>SUPERA KVALITETA provides business consulting services in the field of medicinal products for the implementation, maintenance and improvement of:<\/p>\n<ul>\n<li>Good Manufacturing Practice &#8211; GMP<\/li>\n<li>Good Distribution Practice &#8211; GDP<\/li>\n<li>Good Laboratory Practice &#8211; GLP<\/li>\n<li>Good Clinical Practice -GCP<\/li>\n<li>Good Pharmacovigilance Practice &#8211; GVP<\/li>\n<li>Good Automated Manufacturing Practice &#8211; GAMP<\/li>\n<li>Quality Management System &#8211; QMS<\/li>\n<\/ul>\n<p>Our activities also include project planning and their regular review, support during product development and portfolio management, design for renovated or new facilities (laboratories or pharmaceutical manufacturing facilities), as well as support during the development and validation of computer systems (SDLC), data integrity, and compliance with GAMP. We are able to train staff at all levels of the organization and interact with them, establish and motivate teams to process improvements and lead company-wide programs that result in significant cost reductions. With our help, our clients have successfully implemented and improved their quality system, aligned it with Good Practice Requirements (GxP) and received approvals or certifications from regulatory bodies such as the Ministry of Health of Republic of Croata, US FDA, EU, PIC \/ s and WHO.<\/p>\n<p>We also perform internal audits and third-party audits in compliance with applicable regulatory requirements and standards. We organize and perform <a href=\"https:\/\/www.supera-kvaliteta.hr\/seminari\/\">in-house trainings<\/a> in English language for GxP, risk management, internal audit performing and other topics in the field of medicinal products.<\/p>\n<p>Od 2013. aktivno podr\u017eavamo veliki broj postoje\u0107ih i novoosnovanih veledrogerije u uspostavi i unapre\u0111enju njihovih sustava kvalitete i udovoljavanja zahtjevima nacionalnih zakona i pravilnika u prometu lijekova na veliko i EU GDP smjernicama. Odr\u017eali smo vi\u0161e od 200 seminara koji su obuhvatili razli\u010dite teme iz podru\u010dja prometa na veliko na kojima je sudjelovalo vi\u0161e tisu\u0107a polaznika. Kontinuirano odr\u017eavamo edukacije za odgovorne osobe za promet lijekova na veliko (Responsible person; RP) a vi\u0161e o seminarima pogledajte na<a href=\"https:\/\/www.supera-kvaliteta.hr\/seminari\/\"><span> <\/span>rasporedu seminara<\/a>.<\/p>\n<p>Uz na\u0161u pomo\u0107, na\u0161i klijenti su uspje\u0161no implementirali i unaprijedili svoje sustave kvalitete, uskladili ih sa zahtjevima dobrih praksa (GxP) i dobili odobrenja ili certifikate od regulatornih tijela kao \u0161to su Ministarstvo zdravstva RH, HALMED-a, EU GMP regulatornih agencija dr\u017eava \u010dlanica, farmaceutske inspekcije dr\u017eava u regiji, US FDA, PIC\/s i WHO.<\/p>\n<p>Korisnici na\u0161ih usluga poslovnog savjetovanja kao i polaznici na\u0161ih seminara iz podru\u010dja lijekova dolaze iz Hrvatske, Slovenije, Bosne i Hercegovine, Srbije, Makedonije, Crne Gore, Ukrajine, \u010ce\u0161ke, \u0160vicarske, Velike Britanije, Francuske, Malte, Cipra, Turske, Indije, Kube.<\/p>\n<p>Provodimo interne<span> <\/span><a href=\"https:\/\/www.supera-kvaliteta.hr\/en\/audits\/\">audite<\/a> kao i<span> <\/span><a href=\"https:\/\/www.supera-kvaliteta.hr\/en\/audits\/\">audite<span> <\/span>tre\u0107ih strana<\/a><span> <\/span>u skladu s primjenjivim regulatornim zahtjevima i standardima.<\/p>\n<p>Za kompanije sa sjedi\u0161tem izvan EU (kompanije s poslovnim nastanom u tre\u0107im zemljama) nudimo<a href=\"https:\/\/www.supera-kvaliteta.hr\/en\/gmp-representation\/\"><span> <\/span>uslugu<span> <\/span>zastupanja u procesu dobivanja EU<span> <\/span>GMP certifikata<span> <\/span><\/a>od strane Hrvatske Agencije za lijekove i medicinske proizvode (HALMED).<\/p>\n<p>O dobrim praksama i regulativi za lijekove, provedbi internih audita, upravljanju rizicima i drugim temama iz podru\u010dja proizvodnje, kontrole, skladi\u0161tenja i prometa lijekova na veliko lijekova mo\u017eete saznati vi\u0161e na na\u0161im<a href=\"https:\/\/www.supera-kvaliteta.hr\/en\/in-house-courses\/\"><span> <\/span>internim seminarima<\/a><span> <\/span>koji mogu biti potpuno prilago\u0111eni va\u0161im specifi\u010dnim potrebama. Informacije o seminarima otvorenog tipa potra\u017eite na<span> <\/span><a href=\"https:\/\/www.supera-kvaliteta.hr\/seminari\/\">rasporedu seminara<\/a>.<\/p>\n<\/div><\/div><div class=\"w-gallery fit_cover type_grid action_popup_image ratio_4x3 count_4\" style=\"--columns:4;--items-gap:10px;\"><div class=\"w-gallery-list\"><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"640\" height=\"426\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_headache-1540220_640.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_headache-1540220_640.jpg 640w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_headache-1540220_640-300x200.jpg 300w\" sizes=\"auto, (max-width: 640px) 100vw, 640px\" \/><\/div><a class=\"w-gallery-item-link\" aria-label=\"lijekovi_headache-1540220_640\" href=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_headache-1540220_640.jpg\"><\/a><\/div><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"640\" height=\"384\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_tablets-1001224_640.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_tablets-1001224_640.jpg 640w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_tablets-1001224_640-300x180.jpg 300w\" sizes=\"auto, (max-width: 640px) 100vw, 640px\" \/><\/div><a class=\"w-gallery-item-link\" aria-label=\"lijekovi_tablets-1001224_640\" href=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/lijekovi_tablets-1001224_640.jpg\"><\/a><\/div><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920-1024x683.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920-1024x683.jpg 1024w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920-300x200.jpg 300w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920.jpg 1920w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/div><a class=\"w-gallery-item-link\" aria-label=\"Lijekovi_medicine-1309148_1920\" href=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_medicine-1309148_1920.jpg\"><\/a><\/div><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"424\" height=\"283\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_oprema_Fotolia_23974007_XS.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_oprema_Fotolia_23974007_XS.jpg 424w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_oprema_Fotolia_23974007_XS-300x200.jpg 300w\" sizes=\"auto, (max-width: 424px) 100vw, 424px\" \/><\/div><a class=\"w-gallery-item-link\" aria-label=\"manufacturing facility in pharmaceutical factory\" href=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Lijekovi_oprema_Fotolia_23974007_XS.jpg\"><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":992,"parent":0,"menu_order":23,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-995","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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