{"id":15737,"date":"2024-11-19T09:32:37","date_gmt":"2024-11-19T09:32:37","guid":{"rendered":"https:\/\/netsteril.com\/?p=15737"},"modified":"2024-11-19T15:04:08","modified_gmt":"2024-11-19T15:04:08","slug":"regulation-and-standards-for-the-manufacture-atmp","status":"publish","type":"post","link":"https:\/\/netsteril.com\/en\/blog\/regulation-and-standards-for-the-manufacture-atmp\/","title":{"rendered":"Does Annex 1 of the GMPs apply to the manufacturing of ATMPs?"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1414.4px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>The answer is clear: <strong>NO<\/strong>. Annex 1 (\ud835\ude14\ud835\ude22\ud835\ude2f\ud835\ude36\ud835\ude27\ud835\ude22\ud835\ude24\ud835\ude35\ud835\ude36\ud835\ude33\ud835\ude26 \ud835\ude30\ud835\ude27 \ud835\ude1a\ud835\ude35\ud835\ude26\ud835\ude33\ud835\ude2a\ud835\ude2d\ud835\ude26 \ud835\ude14\ud835\ude26\ud835\ude25\ud835\ude2a\ud835\ude24\ud835\ude2a\ud835\ude2f\ud835\ude22\ud835\ude2d \ud835\ude17\ud835\ude33\ud835\ude30\ud835\ude25\ud835\ude36\ud835\ude24\ud835\ude35\ud835\ude34) does not apply to ATMPs manufacturing. However, it is surprising that we still find professionals in the field and specialized consultants who defend the opposite and, sometimes, even some poorly informed inspectors.<\/p>\n<p>The position of the regulatory agencies is clear; the <em><strong>Guidelines of Good Manufacturing Practice specific to Advanced Therapy Medicinal Products<\/strong><\/em> in volume 4 of the GMPs were written precisely to cover this type of therapies in a specific way. Something different is that, for a specific point, the guidelines for ATMPs comment that it applies in the same way as described in Annex 1 or, also, that it is good practice to consult Annex 1 as a guide when we detect an ambiguous or missing point in the part corresponding to the ATMPS. However, in the latter case, it would be something that would not apply directly and that would have to be analyzed.<\/p>\n<p><strong>The guidelines for ATMPs of the GMPs already considers that these types of therapies are sterile<\/strong>, in fact, they address the requirements of production in closed systems and the requirements of the aseptic process simulation, to give a few examples. On the other hand, it must be taken into account that the regulatory agents, when drafting the part relating to ATMPs, not only took into account that they are sterile therapies, but also the specificity of this type of product when establishing certain requirements (the production restrictions, for example, of a small molecule, cannot be equated with those of a therapy based on cells or viral vectors).<\/p>\n<div>\n<p>In addition, the Netsteril team had the opportunity to discuss this topic at <a href=\"https:\/\/www.linkedin.com\/company\/a3p-association\/\" target=\"_blank\" rel=\"noopener\">the A3P Association event<\/a> <strong>&#8220;1 year after the application of Annex 1&#8221;<\/strong> with Matilde Moreno Garc\u00eda, from the AEMPS, and other professionals from Spain, France and Belgium, who have also successfully defended this position in different forums.<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-left kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;left&quot;,&quot;id&quot;:&quot;15737&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;1&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;post&quot;,&quot;legend&quot;:&quot;5\\\/5 - (1 vote)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;Does Annex 1 of the GMPs apply to the manufacturing of ATMPs?&quot;,&quot;width&quot;:&quot;142.5&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (1 vote)    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":15742,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[89],"tags":[],"class_list":["post-15737","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Regulation and standards for the manufacture of ATMPs<\/title>\n<meta name=\"description\" content=\"Explanation of why Annex 1 of the GMPs does not apply to the manufacture of advanced therapy medicinal products (ATMPs) and what good practices are.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/netsteril.com\/en\/wp-json\/wp\/v2\/posts\/15737\" 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M\u00e1ster en Bioingenier\u00eda por el IQS de Barcelona. 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