{"id":4103,"date":"2021-10-18T23:54:06","date_gmt":"2021-10-18T16:54:06","guid":{"rendered":"https:\/\/gmpgroups.com.vn\/uncategorized\/dich-vu-tu-van-tieu-chuan-gxp-iso\/"},"modified":"2023-05-26T13:54:03","modified_gmt":"2023-05-26T06:54:03","slug":"gxp-iso-standard-consulting-services","status":"publish","type":"post","link":"https:\/\/gmpgroups.com.vn\/en\/uncategorized\/gxp-iso-standard-consulting-services\/","title":{"rendered":"GxP &#038; ISO Standard Consulting Services"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000; font-size: 20px;\">One of the biggest concerns of the pharmaceutical, cosmetic, food and medical devices industries. It&#8217;s the quality of your products. The GxP standard is a set of regulations and guidelines to solve this problem systematically and effectively. Join GMP Groups to learn more about the GxP standard in the article below.<\/span><\/p>\n<h2 style=\"text-align: justify;\"><span style=\"color: #253d8f; font-size: 24px;\"><b>What is the GxP &amp; ISO standard?<\/b><\/span><\/h2>\n<p><span style=\"font-size: 20px;\">The GxP standards were established by the U.S. Food and Drug Administration. The term surrounds many different regulations in many different areas. What is GxP? The letter G stands for &#8220;Good&#8221; and P stands for &#8220;Practice&#8221;. &#8216;X&#8217; in the middle is a variable that can be replaced by any word that completes the acronym appropriately.<\/span><\/p>\n<p><span style=\"font-size: 20px;\">These regulations and guidelines focus primarily on:<\/span><\/p>\n<p><span style=\"font-size: 20px;\">\u2013 Product traceability<\/span><\/p>\n<p><span style=\"font-size: 20px;\">\u2013 Accountability<\/span><\/p>\n<p><span style=\"font-size: 20px;\">\u2013 Data integrity<\/span><\/p>\n<p><span style=\"font-size: 20px;\">Although the GxP regulations include many different sets of regulations, the most common are GMP, GLP, GSP and GDP.<\/span><\/p>\n<div id=\"attachment_2837\" style=\"width: 2570px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-2837\" class=\"size-full wp-image-2837\" src=\"http:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-scaled.jpg\" alt=\"T\u01b0 v\u1ea5n ti\u00eau chu\u1ea9n GxP v\u00e0 ISO\" width=\"2560\" height=\"1071\" srcset=\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-scaled.jpg 2560w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-300x126.jpg 300w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-1024x428.jpg 1024w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-768x321.jpg 768w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-1536x643.jpg 1536w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-2048x857.jpg 2048w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-720x301.jpg 720w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-675x282.jpg 675w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-560x234.jpg 560w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-210x88.jpg 210w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-660x276.jpg 660w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-600x251.jpg 600w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/tu-van-tieu-chuan-gxp-iso-354x148.jpg 354w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/><p id=\"caption-attachment-2837\" class=\"wp-caption-text\"><em><span style=\"font-size: 16px; color: #000000;\">GxP and ISO standard consultancy<\/span><\/em><\/p><\/div>\n<h3 style=\"text-align: justify;\"><span style=\"color: #000000; font-size: 20px;\"><span style=\"color: #253d8f;\"><a style=\"color: #253d8f;\" href=\"http:\/\/gmpgroups.com.vn\/solutions\/gmp\/\"><b>GMP Standard<\/b><\/a><\/span><b> (Good Manufacturing Practices- Good Manufacturing Practices)<\/b><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000; font-size: 20px;\">GMP is part of a quality management system that ensures factory conditions (infrastructure), human conditions and controls production processes to meet the standards of hygiene and safety provided to consumers, eliminating the risk of cross-contamination and confusion.<\/span><\/p>\n<h3 style=\"text-align: justify;\"><span style=\"color: #000000; font-size: 20px;\"><a style=\"color: #000000;\" href=\"http:\/\/gmpgroups.com.vn\/solution\/tieu-chuan-glp-la-gi-tu-van-ap-dung-tieu-chuan-glp\/\"><b><span style=\"color: #253d8f;\">GLP Standard<\/span><\/b><\/a><b> (Good Laboratory Practice \u2013 Good laboratory practice)<\/b><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000; font-size: 20px;\">GLP is a set of principles and standards on quality management system related to the process of organization and conditions for conducting non-clinical research in pharmaceutical activities for human health and environmental safety that are planned, implemented, monitored, recorded, storage and reporting.\u00a0<\/span><\/p>\n<h3 style=\"text-align: justify;\"><span style=\"color: #000000; font-size: 20px;\"><span style=\"color: #253d8f;\"><a style=\"color: #253d8f;\" href=\"http:\/\/gmpgroups.com.vn\/solution\/tu-van-tieu-chuan-gsp-va-kho-dat-chuan-gsp-trong-nganh-duoc\/\"><b>GSP Standard<\/b><\/a><\/span><b> (Good Storage Practices \u2013 Good practice of preserving medicines)<\/b><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400; color: #000000; font-size: 20px;\">GSP is a set of principles and standards relating to appropriate measures for the preservation and transportation of raw materials and products at all stages of production, storage, storage, transportation and distribution of drugs in order to ensure and maintain the best safety and quality of drugs, medicinal materials through adequate control throughout the storage process.\u00a0<\/span><\/p>\n<p><span style=\"color: #000000; font-size: 20px;\"><strong><span style=\"color: #253d8f;\">GDP standards <\/span>(Good Distribution Practices &#8211; Good practice of drug distribution)<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px; color: #000000;\">This standard sets out strict requirements to ensure the comprehensive quality of drugs during the transportation and distribution of drugs to ensure the supply of drugs to consumers in a timely, complete and quality manner.\u00a0<\/span><\/p>\n<h3 style=\"text-align: justify;\"><span style=\"color: #000000; font-size: 20px;\"><a style=\"color: #000000;\" href=\"http:\/\/gmpgroups.com.vn\/solutions\/iso\/\"><b><span style=\"color: #253d8f;\">ISO Standards<\/span><\/b><\/a><b> (International Organization for Standardization \u2013 International Standardization Organization)<\/b><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">Not only does it stop at meeting the standards of domestic law, but businesses also try to meet international standards including ISO standards.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">ISO is an international set of standards set by ISO to make everything done in accordance with the standards including providing international standard specifications to ensure products, services and systems, ensuring quality, safety and efficiency.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">Some of iso&#8217;s common standards such as:<\/span><\/p>\n<div id=\"attachment_2834\" style=\"width: 2570px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-2834\" class=\"size-full wp-image-2834\" src=\"http:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-scaled.jpg\" alt=\"C\u00e1c ti\u00eau chu\u1ea9n ISO ti\u00eau bi\u1ec3u \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n b\u1edfi GMP Groups\" width=\"2560\" height=\"1425\" srcset=\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-scaled.jpg 2560w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-300x167.jpg 300w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-1024x570.jpg 1024w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-768x428.jpg 768w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-1536x855.jpg 1536w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-2048x1140.jpg 2048w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-720x401.jpg 720w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-675x376.jpg 675w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-560x312.jpg 560w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-210x117.jpg 210w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-660x367.jpg 660w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-600x334.jpg 600w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/cac-tieu-chuan-iso-tieu-bieu-gmp-groups-tu-van-354x197.jpg 354w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/><p id=\"caption-attachment-2834\" class=\"wp-caption-text\"><em><span style=\"font-size: 16px; color: #000000;\">Typical ISO standards are advised by GMP Groups<\/span><\/em><\/p><\/div>\n<h2 style=\"text-align: justify;\"><span style=\"color: #253d8f; font-size: 24px;\"><b>GxP &amp;ISO Quality Management System Consulting Service at GMP Groups<\/b><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">Building a quality management system is not easy. This requires investment in people, equipment and related procedures. Therefore, most businesses need the support and advice of a specialized unit in the field of quality management consultancy.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">As a company operating for many years in the field of quality management consultancy, GMP Groups has a team of experts who are experienced pharmacists and engineers leading in the quality system of GMP, GSP, GLP &amp; ISO system deployment.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">GMP GROUPS ensures comprehensive consultation of GMP, GSP, GLP &amp;ISO systems until certification is received including:<\/span><\/p>\n<h3 style=\"text-align: justify;\"><span style=\"color: #253d8f; font-size: 20px;\"><b>\u2013 GxP Standard Consultancy<\/b><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">+ Consulting on completing the premises of production, testing and warehouse technology<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">+ Consulting to complete the overall premises, investment items in accordance with the regulations to meet the requirements of customers<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">+ Catalog equipment for production (GMP), testing (GLP) and warehouse (GSP)<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">+ Supporting the selection of equipment, tools and consumables for the factory<\/span><\/p>\n<h3 style=\"text-align: justify;\"><span style=\"color: #253d8f; font-size: 20px;\"><b>\u2013 Basic training of GMP\/GLP\/GSP\/GDP\/ISO standards<\/b><\/span><\/h3>\n<p><span style=\"font-size: 20px;\">+ Develop a training plan<\/span><\/p>\n<p><span style=\"font-size: 20px;\">+ General training in GMP\/GLP\/GSP\/GDP\/ISO<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">+ Training knowledge on system appraisal: Assessment of HVAC system, production environment, domestic water system, RO water, distilled water, pneumatic, storage conditions, equipment appraisal, production process appraisal, hygiene process appraisal<\/span><\/p>\n<h3 style=\"text-align: justify;\"><span style=\"color: #253d8f; font-size: 20px;\"><b>\u2013 Instructions for drafting dossiers and documents\u00a0<\/b><\/span><\/h3>\n<p><span style=\"font-size: 20px;\">+ Cataloging of SOP documents and dossiers<\/span><\/p>\n<p><span style=\"font-size: 20px;\">+ Instructions for drafting SOP systems related to GMP\/GLP\/GSP\/GDP\/ISO<\/span><\/p>\n<p><span style=\"font-size: 20px;\">+ Develop the original appraisal plan<\/span><\/p>\n<p><span style=\"font-size: 20px;\">+ Guidance on building IQ, OQ, PQ for production equipment, HVAC system, RO water treatment system, distilled water.<\/span><\/p>\n<p><span style=\"font-size: 20px;\">+ Build a water quality handbook<\/span><\/p>\n<p><span style=\"font-size: 20px;\">+ Guidance on the development of a scheme for appraisal of the production environment<\/span><\/p>\n<p><span style=\"font-size: 20px;\">+ Guidance on building GLP\/GSP\/ISO-related SOPs<\/span><\/p>\n<div id=\"attachment_2888\" style=\"width: 810px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-2888\" class=\"size-full wp-image-2888\" src=\"http:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1.jpg\" alt=\"\u0110\u1ed9i ng\u0169 chuy\u00ean m\u00f4n t\u01b0 v\u1ea5n h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a GMP Groups\" width=\"800\" height=\"533\" srcset=\"https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1.jpg 800w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-300x200.jpg 300w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-768x512.jpg 768w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-450x300.jpg 450w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-720x480.jpg 720w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-675x450.jpg 675w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-560x373.jpg 560w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-210x140.jpg 210w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-660x440.jpg 660w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-600x400.jpg 600w, https:\/\/gmpgroups.com.vn\/wp-content\/uploads\/2021\/07\/doi-ngu-chuyen-mon-tu-van-gmp-iso-1-354x236.jpg 354w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><p id=\"caption-attachment-2888\" class=\"wp-caption-text\"><em><span style=\"font-size: 16px; color: #000000;\">GMP Groups&#8217; quality management system consulting team<\/span><\/em><\/p><\/div>\n<h3 style=\"text-align: justify;\"><span style=\"color: #253d8f; font-size: 20px;\"><b>\u2013\u00a0Completing the application for evaluation and certification of GxP standards<\/b><\/span><\/h3>\n<p><span style=\"font-size: 20px;\">+ Complete IQ, OQ, DQ assessments for equipment, HVAC system, water, pneumatic<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">+ Guidance on production and testing of 03 appraisal lots, guidance on completing appraisal of production process<\/span><\/p>\n<p><span style=\"font-size: 20px;\">+ Instructions for completing the application for evaluation<\/span><\/p>\n<p><span style=\"font-size: 20px; color: #333399;\"><strong>\u2013 Conduct self-inspection and overcome the existence after self-inspection<\/strong><\/span><\/p>\n<p><span style=\"font-size: 20px; color: #333399;\"><strong>\u2013 Overcoming inappropriate points after the evaluation team assesses GMP\/GLP\/GSP\/GDP<\/strong><\/span><\/p>\n<p><span style=\"font-size: 20px; color: #333399;\"><strong>\u2013 Together with the investor maintains the system of documents according to GMP\/GLP\/GSP\/GDP for the next assessment.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 20px; color: #000000;\">Refer to some typical certifications we have advised at: <span style=\"color: #253d8f;\"><a style=\"color: #253d8f;\" href=\"http:\/\/gmpgroups.com.vn\/projects\/tu-van-gxp-iso\/\" target=\"_blank\" rel=\"noopener\"><strong>Quality management system standard certification<\/strong><\/a><\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 20px;\">For any questions related to <span style=\"color: #333399;\"><strong>GxP &amp; ISO standard consultancy<\/strong><\/span> in general and details of quality management systems, please contact GMP Groups for direct support from experts.\u00a0<\/span><\/p>\n<p><strong><span style=\"font-size: 20px;\">GMP Groups Joint Stock Company<\/span><\/strong><\/p>\n<p><span style=\"font-size: 20px;\"><strong>Head office<\/strong>: Lot LK20.8, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000; font-size: 20px;\"><b>Hotline<\/b><span style=\"font-weight: 400;\">: 0945.255.457<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000; font-size: 20px;\"><b>Website<\/b><span style=\"font-weight: 400;\">: gmpgroups.com.vn<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000; font-size: 20px;\"><b>Email<\/b><span style=\"font-weight: 400;\">: info@gmpgroups.com.vn<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>One of the biggest concerns of the pharmaceutical, cosmetic, food and medical devices industries. It&#8217;s the quality of your products. The GxP standard is a set of regulations and guidelines to solve this problem systematically and effectively. Join GMP Groups to learn more about the GxP standard in the article below. What is the GxP [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10953,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[309],"tags":[],"class_list":["post-4103","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>GxP &amp; ISO Standard Consulting Services - GMP Groups<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/gmpgroups.com.vn\/en\/uncategorized\/gxp-iso-standard-consulting-services\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GxP &amp; ISO Standard Consulting Services - GMP Groups\" \/>\n<meta property=\"og:description\" content=\"One of the biggest concerns of the pharmaceutical, cosmetic, food and medical devices industries. 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