{"id":1436,"date":"2020-02-03T09:22:20","date_gmt":"2020-02-03T09:22:20","guid":{"rendered":"https:\/\/phrstaging.pharmaroad.hu\/?page_id=1436"},"modified":"2026-02-02T16:11:17","modified_gmt":"2026-02-02T15:11:17","slug":"minosegbiztositas","status":"publish","type":"page","link":"https:\/\/pharmaroad.hu\/en\/minosegbiztositas\/","title":{"rendered":"Quality Management"},"content":{"rendered":"<p><section id=\"bt_section69e22e867349a\"  class=\"boldSection btDivider topSemiSpaced bottomSemiSpaced btDarkSkin gutter inherit wBackground cover\" style=\"background-color:#0c7296;background-image:url('https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2015\/12\/bgn-grad-1.png?fit=2000%2C1333&ssl=1');\"><div class=\"port\"><div class=\"boldCell\"><div class=\"boldCellInner\"><div class=\"boldRow\" ><div class=\"boldRowInner\"><div class=\"rowItem col-md-4 col-ms-12 btTextRight inherit btNoPadding\"  ><div class=\"rowItemContent\" ><\/div><\/div><div class=\"rowItem col-md-8 col-ms-12 btTextLeft animate animate-fadein animate-moveleft inherit btDoublePadding\"  ><div class=\"rowItemContent\" ><div class=\"btClear btSeparator topExtraSmallSpaced noBorder\" ><hr><\/div><div class=\"btClear btSeparator topExtraSmallSpaced noBorder\" ><hr><\/div><header class=\"header btClear large  btNormalDash\" ><div class=\"btSuperTitle\">Pharmaroad Zrt.<\/div><div class=\"dash\"><h2><span class=\"headline\">Quality Management<\/span><\/h2><\/div><\/header><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section id=\"bt_section69e22e8673654\"  class=\"boldSection topSemiSpaced bottomSpaced gutter inherit\" style=\"background-color:#f1f1f1;\"><div class=\"port\"><div class=\"boldCell\"><div class=\"boldCellInner\"><div class=\"boldRow\" ><div class=\"boldRowInner\"><div class=\"rowItem col-md-4 col-ms-12 btTextLeft animate animate-fadein animate-moveup btTextIndent inherit\" style=\"margin-top: -180px;\" ><div class=\"rowItemContent\" style = \"background-color:#ffffff;\"><div class=\"btIconImageRow btIconsHalfHoverPosition\" ><span class=\"btIco btIcoFilledType btIcoMediumSize btIcoAccentColor  btIcoOutline\" ><a href=\"#\"  target = \"no_target\" data-ico-fa=\"&#xf0b1;\" class=\"btIcoHolder\"><em><\/em><\/a><\/span><\/div><div class=\"btClear btSeparator topExtraSmallSpaced noBorder\" ><hr><\/div><header class=\"header btClear medium  btNormalDash\" ><div class=\"btSuperTitle\">MIN\u0150S\u00c9GBIZTOS\u00cdT\u00c1SI VEZET\u0150-HELYETTES, FELEL\u0150S SZEM\u00c9LY<\/div><div class=\"dash\"><h3><span class=\"headline\">Dr. HAMAR ERIKA<\/span><\/h3><\/div><\/header><div class=\"btClear btSeparator topExtraSmallSpaced noBorder\" ><hr><\/div><div class=\"btIconImageRow btIconsNormalPosition\" ><span class=\"btIco btIcoDefaultType btIcoSmallSize btIcoDefaultColor\" ><a href=\"tel:+080023367820\"  target = \"no_target\" data-ico-fa=\"&#xf095;\" class=\"btIcoHolder\"><em><\/em><span class=\"btIcoText\">+36-1-433-0080<\/span><\/a><\/span><\/div><div class=\"btClear btSeparator topExtraSmallSpaced noBorder\" ><hr><\/div><div class=\"btIconImageRow btIconsNormalPosition\" ><span class=\"btIco btIcoDefaultType btIcoSmallSize btIcoDefaultColor\" ><a href=\"mailto:sussie.wolff@medicare.com\"  target = \"no_target\" data-ico-fa=\"&#xf003;\" class=\"btIcoHolder\"><em><\/em><span class=\"btIcoText\">qa@pharmaroad.hu<\/span><\/a><\/span><\/div><div class=\"btClear btSeparator topSemiSpaced bottomSmallSpaced border\" ><hr><\/div><div class=\"bt_bb_masonry_image_grid bt_bb_grid_container bt_bb_columns_1 bt_bb_gap_normal\" data-columns=\"1\"><div class=\"bt_bb_masonry_post_image_content\" data-columns=\"1\"><div class=\"bt_bb_grid_sizer\"><\/div><div class=\"bt_bb_grid_item bt_bb_tile_format11\" data-hw=\"0.6675\" data-src=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/PHR6.jpg?fit=1200%2C801&#038;ssl=1\" data-src-full=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/PHR6.jpg?fit=1920%2C1282&#038;ssl=1\" data-title=\"PHR6\"><div class=\"bt_bb_grid_item_inner\" data-hw=\"0.6675\" ><div class=\"bt_bb_grid_item_inner_image\"><\/div><div class=\"bt_bb_grid_item_inner_content\"><\/div><\/div><\/div><div class=\"bt_bb_grid_item bt_bb_tile_format11\" data-hw=\"0.6675\" data-src=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/PHR10.jpg?fit=1200%2C801&#038;ssl=1\" data-src-full=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/PHR10.jpg?fit=1920%2C1282&#038;ssl=1\" data-title=\"PHR10\"><div class=\"bt_bb_grid_item_inner\" data-hw=\"0.6675\" ><div class=\"bt_bb_grid_item_inner_image\"><\/div><div class=\"bt_bb_grid_item_inner_content\"><\/div><\/div><\/div><div class=\"bt_bb_grid_item bt_bb_tile_format11\" data-hw=\"0.6675\" data-src=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/20200227PharmaRoad0069-scaled.jpg?fit=1200%2C801&#038;ssl=1\" data-src-full=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/20200227PharmaRoad0069-scaled.jpg?fit=2560%2C1709&#038;ssl=1\" data-title=\"20200227PharmaRoad0069\"><div class=\"bt_bb_grid_item_inner\" data-hw=\"0.6675\" ><div class=\"bt_bb_grid_item_inner_image\"><\/div><div class=\"bt_bb_grid_item_inner_content\"><\/div><\/div><\/div><div class=\"bt_bb_grid_item bt_bb_tile_format11\" data-hw=\"0.6675\" data-src=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/20200227PharmaRoad0035-scaled.jpg?fit=1200%2C801&#038;ssl=1\" data-src-full=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/20200227PharmaRoad0035-scaled.jpg?fit=2560%2C1709&#038;ssl=1\" data-title=\"20200227PharmaRoad0035\"><div class=\"bt_bb_grid_item_inner\" data-hw=\"0.6675\" ><div class=\"bt_bb_grid_item_inner_image\"><\/div><div class=\"bt_bb_grid_item_inner_content\"><\/div><\/div><\/div><\/div><\/div><div class=\"btClear btSeparator topSmallSpaced noBorder\" ><hr><\/div><\/div><\/div><div class=\"rowItem col-md-8 col-ms-12 btTextLeft animate animate-fadein inherit btDoublePadding\"  ><div class=\"rowItemContent\" ><div class=\"btClear btSeparator bottomSmallSpaced border\" ><hr><\/div><div class=\"btText\" ><\/p>\n<blockquote>\n<p style=\"text-align: justify;\"><em>\u2026for all participants in the pharmaceutical supply chain quality management plays a key role in operations.  Quality management includes the assurance of a full compliance with the applicable regulatory guidelines, such as the Good Manufacturing Practice (GMP), the Good Distribution Practice (GDP) or the Good Clinical Practice (GCP), as well as adherence to the national laws and regulations and relevant industry standards (ISO) \u2026<\/em><\/p>\n<\/blockquote>\n<p>\n<\/div><div class=\"btClear btSeparator bottomSmallSpaced border\" ><hr><\/div><div class=\"bt_bb_masonry_image_grid bt_bb_grid_container bt_bb_columns_2 bt_bb_gap_normal\" data-columns=\"2\"><div class=\"bt_bb_masonry_post_image_content\" data-columns=\"2\"><div class=\"bt_bb_grid_sizer\"><\/div><div class=\"bt_bb_grid_item bt_bb_tile_format11\" data-hw=\"0.6675\" data-src=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/PHR7.jpg?fit=1200%2C801&#038;ssl=1\" data-src-full=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/PHR7.jpg?fit=1920%2C1282&#038;ssl=1\" data-title=\"PHR7\"><div class=\"bt_bb_grid_item_inner\" data-hw=\"0.6675\" ><div class=\"bt_bb_grid_item_inner_image\"><\/div><div class=\"bt_bb_grid_item_inner_content\"><\/div><\/div><\/div><div class=\"bt_bb_grid_item bt_bb_tile_format11\" data-hw=\"0.6675\" data-src=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/PHR4.jpg?fit=1200%2C801&#038;ssl=1\" data-src-full=\"https:\/\/i0.wp.com\/pharmaroad.hu\/wp-content\/uploads\/2020\/03\/PHR4.jpg?fit=1920%2C1282&#038;ssl=1\" data-title=\"PHR4\"><div class=\"bt_bb_grid_item_inner\" data-hw=\"0.6675\" ><div class=\"bt_bb_grid_item_inner_image\"><\/div><div class=\"bt_bb_grid_item_inner_content\"><\/div><\/div><\/div><\/div><\/div><div class=\"btClear btSeparator bottomSmallSpaced border\" ><hr><\/div><div class=\"btText\" ><\/p>\n<p style=\"text-align: justify;\">For all participants in the pharmaceutical supply chain quality management plays a key role in operations.  Quality management includes the assurance of a full compliance with the applicable regulatory guidelines, such as the Good Manufacturing Practice (GMP), the Good Distribution Practice (GDP) or the Good Clinical Practice (GCP), as well as adherence to the national laws and regulations and relevant industry standards (such as ISO 9001, ISO 14 001, ISO 50 001).  In addition, it also entails strictly meeting all requirements of European directives, regulations and other forms of legislation, such as the Falsified Medicines Directive (FMD) implemented in 2019 or the Medical Devices Regulation (MDR) planned to be implemented in 2020.<\/p>\n<p style=\"text-align: justify;\">A PHARMAROAD-n\u00e1l a helyes nagykereskedelmi gyakorlat \u00e9rv\u00e9nyes\u00fcl\u00e9s\u00e9t a j\u00f3l k\u00e9pzett munkat\u00e1rsak, valamint a forgalmaz\u00e1si tev\u00e9kenys\u00e9g valamennyi mozzanat\u00e1ra kiterjed\u0151 informatikai rendszer biztos\u00edtja. Ez a rendszer lehet\u0151v\u00e9 teszi a teljes term\u00e9kk\u00f6r (gy\u00f3gyszerek, \u00e9trend kieg\u00e9sz\u00edt\u0151k, t\u00e1pszerek, orvostechnikai eszk\u00f6z\u00f6k \u00e9s egy\u00e9b term\u00e9kek) teljes k\u00f6r\u0171 nyomon k\u00f6vethet\u0151s\u00e9g\u00e9t \u00e9s nagyban hozz\u00e1j\u00e1rul ahhoz, hogy a min\u0151s\u00e9gbiztos\u00edt\u00e1si oszt\u00e1ly koll\u00e9g\u00e1i magas fok\u00fa precizit\u00e1ssal m\u0171k\u00f6dtess\u00e9k a v\u00e1llalat min\u0151s\u00e9gir\u00e1ny\u00edt\u00e1si rendszer\u00e9t. A jogszab\u00e1lyi k\u00f6vetelm\u00e9nyeknek megfelel\u0151en, a min\u0151s\u00e9gbiztos\u00edt\u00e1si oszt\u00e1ly koll\u00e9g\u00e1i kiemelt figyelmet biztos\u00edtanak a gy\u00f3gyszerhamis\u00edt\u00e1s elleni direkt\u00edv\u00e1hoz kapcsol\u00f3d\u00f3 feladatok (verifik\u00e1ci\u00f3, kijelent\u00e9s, hiba\u00fczenet kezel\u00e9s, stb.) szakszer\u0171 lebonyol\u00edt\u00e1s\u00e1ra is.<\/p>\n<p style=\"text-align: justify;\">B\u00e1rmely gy\u00f3gyszer-nagykereskedelmi tev\u00e9kenys\u00e9g v\u00e9gz\u00e9s\u00e9nek el\u0151felt\u00e9tele az illet\u00e9kes nemzet\u00e1llami hat\u00f3s\u00e1g \u00e1ltal ki\u00e1ll\u00edtott enged\u00e9ly megszerz\u00e9se.\u00a0 Ezen enged\u00e9lyeztet\u00e9si folyamat kapcs\u00e1n a PHARMAROAD sz\u00e9lesk\u00f6r\u0171 min\u0151s\u00e9gbiztos\u00edt\u00e1si seg\u00edts\u00e9get ny\u00fajt b\u00e9rrakt\u00e1roz\u00f3i \u00e9s egy\u00e9b partnerei sz\u00e1m\u00e1ra, mely az al\u00e1bbi konkr\u00e9t szolg\u00e1ltat\u00e1sokat foglalja mag\u00e1ba:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Assistance in selecting the correct type of Wholesale Distribution Authorization (WDA) based on the business needs, product portfolio, partners and processes of the applying company;<\/li>\n<li>Assistance in selecting the correct type of Wholesale Distribution Authorization (WDA) based on the business needs, product portfolio, partners and processes of the applying company;<\/li>\n<li>Provision of quality management personnel including the Responsible Person to be named on the WDA application;<\/li>\n<li>Assistance in the administrative procedures (contracts, verification documentation, etc.) pertaining to the selection of business partners, suppliers and vendors;<\/li>\n<li>Assistance in managing any additional documentary requirements to resolve discrepancies or provide corrections as requested by the regulatory agency after the submission of the WDA application;<\/li>\n<li>Provision of an inventory management system that is duly connected to the required databases within the European Medicine Verification System (EMVS) and equipped with a remote access function allowing the applying partner to manage certain inventory actions offsite;<\/li>\n<li>Assistance during the regulatory inspection conducted at the warehousing facility of the applying partner.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The successful acquisition of a WDA is also subject to finding an operational base locally or establishing a relationship with an existing logistics service provider. Our company allows several business partners to use its facilities as a logistics base in Hungary while offering the following quality management related services:<\/p>\n<ul>\n<li style=\"text-align: justify;\">Provision of quality management personnel including the Responsible Person to be in charge of all quality management processes;<\/li>\n<li style=\"text-align: justify;\">Physical management of incoming consignments (qualitative and quantitative checks, sampling, etc.) arriving from international or local manufacturing facilities;<\/li>\n<li style=\"text-align: justify;\">Review and handling all logistics and quality management related documentation pertaining to incoming consignments arriving from international or local manufacturing facilities;<\/li>\n<li style=\"text-align: justify;\">Quality management of the entire order fulfilment process including all elements of picking, reviewing, packing and delivery of the outgoing consignments;<\/li>\n<li style=\"text-align: justify;\">Execution of all processes related to the Falsified Medicines Directive (FMD) including product data upload, verification, decommissioning and alert management;<\/li>\n<li style=\"text-align: justify;\">Assistance regarding all quality management related processes, such as the handling and documenting product recalls, returns, complaints, deviations, corrective and preventive action, etc;<\/li>\n<li style=\"text-align: justify;\">Assistance regarding all quality management related processes, such as the handling and documenting product recalls, returns, complaints, deviations, corrective and preventive action, etc;<\/li>\n<\/ul>\n<p>\n<\/div><div class=\"btClear btSeparator topSmallSpaced bottomSmallSpaced border\" ><hr><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section id=\"bt_section69e22e86751ad\"  class=\"boldSection topSemiSpaced bottomSemiSpaced btDarkSkin gutter inherit btAleternateColorBackground\" ><div class=\"port\"><div class=\"boldCell\"><div class=\"boldCellInner\"><div class=\"boldRow\" ><div class=\"boldRowInner\"><div class=\"rowItem col-md-8 col-ms-12 btTextLeft animate animate-fadein animate-moveup btMiddleVertical\"  ><div class=\"rowItemContent\" ><header class=\"header btClear medium  btNormalDash\" ><div class=\"btSuperTitle\">We are constantly looking for talented individuals interested in joining our company<\/div><div class=\"dash\"><h3><span class=\"headline\">Join us<\/span><\/h3><\/div><\/header><\/div><\/div><div class=\"rowItem col-md-4 col-ms-12 btTextRight animate animate-fadein animate-moveup btMiddleVertical\"  ><div class=\"rowItemContent\" ><a href=\"https:\/\/pharmaroad.hu\/en\/karrier\/\" class=\"btBtn btBtn btnOutlineStyle btnLightColor btnSmall btnNormalWidth btnRightPosition btnNoIcon\" ><span class=\"btnInnerText\">Career<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/p>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1436","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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