{"id":15622,"date":"2023-05-19T00:00:00","date_gmt":"2023-05-19T00:00:00","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/ecas-guide-to-compliant-equipment-design\/"},"modified":"2023-07-27T11:47:25","modified_gmt":"2023-07-27T11:47:25","slug":"ecas-guide-to-compliant-equipment-design","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/","title":{"rendered":"ECA\u2019s guide to compliant equipment design"},"content":{"rendered":"\n<p>Since the new Annex 1 came into force to the GMP&#8217;s, the requirements for equipment used in pharmaceutical productions is increased. <strong>Each pharmaceutical process requires the careful design of the needed equipment\u00a0<\/strong>in order to provide the expected efficiency and performance, and in pharmaceutical manufacturing, a further step of complexity may be represented by the need to handle highly potent active pharmaceutical ingredients.<\/p>\n\n\n\n<p>To facilitate the correct&nbsp;<strong>design of equipment compliant to GMPs<\/strong>, a new&nbsp;<a href=\"https:\/\/www.eca-foundation.org\/news\/eca-publishes-new-guide-on-gmp-compliant-equipment-design.html\" target=\"_blank\" rel=\"noreferrer noopener\">guidance document<\/a>&nbsp;has been published by the&nbsp;<strong>ECA Foundation<\/strong>. <\/p>\n\n\n\n<p>The first part of the document discusses&nbsp;<strong>general requirements&nbsp;<\/strong>that should always be part of the design of GMP-compliant equipment: the equipment must not adversely affect the&nbsp;<strong>product quality<\/strong>, it must be&nbsp;<strong>easy to clean<\/strong>, it must comply with&nbsp;<strong>applicable technical rules<\/strong>, and it must be&nbsp;<strong>fit for its intended use<\/strong>. <strong>User requirement specifications&nbsp;<\/strong>(URS) are the key document to demonstrate equipment is fit for the intended use, as stated by GMP Annex 15 (2015). The ECA guidance suggests translating the URS in&nbsp;<strong>a technical version to be submitted to the potential equipment supplier<\/strong>. The management of documentation along the&nbsp;<strong>design life cycle&nbsp;<\/strong>of a new piece of equipment is also taken into consideration. <\/p>\n\n\n\n<p>The&nbsp;<strong>extensive use of data&nbsp;<\/strong>to monitor and document pharmaceutical manufacturing process represents another area of great attention. Requirements relevant to the&nbsp;<strong>design of validated computerised systems, data protection and data integrity&nbsp;<\/strong>must be kept in mind. ECA\u2019s experts highlight the need to&nbsp;<strong>carefully delimitate areas subject to validation and their extention<\/strong>, particularly with reference to&nbsp;<strong>automated systems<\/strong>.<\/p>\n\n\n\n<p>To learn more on this topic visit the <a href=\"https:\/\/eipg.eu\/ecas-guide-to-compliant-equipment-design\/\">EIPG website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Since the new Annex 1 came into force to the GMP&#8217;s, the requirements for equipment used in pharmaceutical productions is increased. Each pharmaceutical process requires the careful design of the needed equipment\u00a0in order to provide the expected efficiency and performance, and in pharmaceutical manufacturing, a further step of complexity may be represented by the need [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":15908,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[687],"tags":[614,721,674,619],"class_list":{"0":"post-15622","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-eipg-news","8":"tag-eipg","9":"tag-gmp","10":"tag-pharmaceuticals","11":"tag-quality-control"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ECA\u2019s guide to compliant equipment design - MakingPharmaIndustry<\/title>\n<meta name=\"description\" content=\"Since the new Annex 1 came into force to the GMP&#039;s, the requirements for equipment used in pharmaceutical productions is increased.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ECA\u2019s guide to compliant equipment design - MakingPharmaIndustry\" \/>\n<meta property=\"og:description\" content=\"Since the new Annex 1 came into force to the GMP&#039;s, the requirements for equipment used in pharmaceutical productions is increased.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/\" \/>\n<meta property=\"og:site_name\" content=\"MakingPharmaIndustry\" \/>\n<meta property=\"article:published_time\" content=\"2023-05-19T00:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-07-27T11:47:25+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/makingpharmaindustry.it\/wp-content\/uploads\/2023\/07\/EIPG-news.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"720\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Valentina Parrella\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Valentina Parrella\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/\"},\"author\":{\"name\":\"Valentina Parrella\",\"@id\":\"https:\/\/makingpharmaindustry.it\/en\/#\/schema\/person\/6c2a2cb5a6dc47527ff5eb31dab7d42f\"},\"headline\":\"ECA\u2019s guide to compliant equipment design\",\"datePublished\":\"2023-05-19T00:00:00+00:00\",\"dateModified\":\"2023-07-27T11:47:25+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/\"},\"wordCount\":292,\"commentCount\":0,\"image\":{\"@id\":\"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/makingpharmaindustry.it\/wp-content\/uploads\/2023\/07\/EIPG-news.jpg\",\"keywords\":[\"EIPG\",\"GMP\",\"pharmaceuticals\",\"quality control\"],\"articleSection\":[\"EIPG NEWS\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/\",\"url\":\"https:\/\/makingpharmaindustry.it\/en\/eipg-news\/ecas-guide-to-compliant-equipment-design\/\",\"name\":\"ECA\u2019s guide to compliant equipment design - 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