{"id":24576,"date":"2024-10-22T10:32:53","date_gmt":"2024-10-22T08:32:53","guid":{"rendered":"https:\/\/www.bcsoa.it\/?page_id=24576"},"modified":"2025-06-17T11:46:59","modified_gmt":"2025-06-17T09:46:59","slug":"quality-by-design-nel-settore-pharma","status":"publish","type":"page","link":"https:\/\/www.bonfiglioliconsulting.com\/it\/articoli\/quality-by-design-nel-settore-pharma\/","title":{"rendered":"Quality by Design nel settore Pharma | White Paper"},"content":{"rendered":"<div id=\"saz-block-block_a27973d6f0094508541d32347c78776b\" class=\"d-none saz-block saz-block-acf-hero-servizi  bg-light bg-hero-servizi-eventi hero_overlay_parent vv lazyload\"\n     style=\"background:inherit; background-size:cover;\" data-bg=\"url(https:\/\/www.bonfiglioliconsulting.com\/wp-content\/uploads\/2021\/05\/laboratory-glassware-orizz.jpg) center top no-repeat transparent\">\n    <div class=\"hero_overlay\"><\/div>\n    <div class=\"container hero_content\">\n        <div class=\"row align-items-end\">\n            <div class=\"col-12\">\n                 \n                    <div class=\"mt-3 mb-2 text-white\"><div class=\"breadcrumbs\"><span property=\"itemListElement\" typeof=\"ListItem\"><a property=\"item\" typeof=\"WebPage\" title=\"Vai a Bonfiglioli Consulting.\" href=\"https:\/\/www.bonfiglioliconsulting.com\/it\" class=\"home\"><span property=\"name\">Home<\/span><\/a><meta property=\"position\" content=\"1\"><\/span><\/div><script type=\"application\/ld+json\">{\"@context\":\"http:\/\/schema.org\",\"@type\":\"BreadcrumbList\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"item\":{\"@id\":\"https:\/\/www.bonfiglioliconsulting.com\/it\",\"name\":\"Bonfiglioli Consulting\"}}]}<\/script><\/div>\n                                \n                                    <h1 class=\"has-huge-font-size font-weight-bold mb-0 text-white\">Quality by Design e il mondo Pharma<\/h1>\n                                                    <h2 class=\"has-medium-font-size my-3 font-weight-normal text-white\">Un approccio strategico alla Qualit\u00e0 nel settore farmaceutico<\/h2>\n                                <div class=\"mb-5 pb-4 pb-md-5\"><\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n    <svg class=\"onda-destra\" id=\"onda\" data-name=\"onda\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 180\"><path class=\"cls-1\" d=\"M0,180H1000V.4S458.72-.5,279.85.4c-49,.25-68.29,7.31-161.7,105.9C94.46,131.3,49.5,174.7,0,180Z\" transform=\"translate(0 0)\" style=\"fill: #ffffff\"\/><\/svg>\n<\/div>\n\n\n<section class=\"n_archive_hero lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(https:\/\/www.bonfiglioliconsulting.com\/wp-content\/uploads\/2021\/05\/laboratory-glassware-orizz.jpg)\"> \n    <div class=\"container h-100 position-relative\">\n        <div class=\"d-flex items-center h-100\">\n            <div class=\"n_archive_hero_content align-self-end text-white\">\n                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Pharma<\/h1>\n                                \n                                    <div class=\"n_archive_desc\"> \n                     <p class=\"text-white\">\n                       Un approccio strategico alla Qualit\u00e0 nel settore farmaceutico                     <\/p>\n                    <\/div>  \n                                \n\n<\/div>\n        <\/div>\n    <\/div>\n    <div class=\"right_white_shape\">\n        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 180\">\n            <path class=\"cls-1\" d=\"M0,180H1000V.4S458.72-.5,279.85.4c-49,.25-68.29,7.31-161.7,105.9C94.46,131.3,49.5,174.7,0,180Z\" transform=\"translate(0 0)\"><\/path>\n        <\/svg>\n    <\/div>\n<\/section><div id=\"saz-block-id-6CbDVHt3Nz02\" class=\"saz-block saz-block\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-QfkaYBaKIRZh\" class=\"saz-block saz-block-core-spacer saz-block-height-60px\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-UvCe3qjn6ZTp\" class=\"saz-block saz-block\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-LgNOf7NPALu2\" class=\"saz-block saz-block-core-heading saz-block-level-array\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n<h3 class=\"wp-block-heading\"><strong>Quality by Design e l&#8217;Industria Farmaceutica<\/strong><\/h3>\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-UD0xJ1SiOX8Q\" class=\"saz-block saz-block\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-DChLCkTgILHG\" class=\"saz-block saz-block-core-paragraph\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n<p>Il concetto di Quality by Design (QbD) rappresenta una pietra miliare nell&#8217;evoluzione del Quality Management, soprattutto nel settore farmaceutico. Questo approccio, profondamente radicato nelle teorie introdotte da <strong>Joseph Juran<\/strong> nel suo celebre <strong>Quality Control Handbook <\/strong>del 1951, promuove l&#8217;idea che la qualit\u00e0 debba essere &#8220;progettata&#8221; all&#8217;interno del processo, anzich\u00e9 verificata attraverso controlli ex-post Quality Gate. Juran introdusse, cos\u00ec, il concetto di <strong>Built-in Quality<\/strong>, sostenendo che <strong>la qualit\u00e0 dei prodotti dipende da processi disegnati per essere robusti ed efficienti<\/strong>, non da controlli successivi al processo.<\/p>\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-kqdqgk3mJMhQ\" class=\"saz-block saz-block\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n\n<\/div><\/div><\/div><\/div><div class=\"wp-block-image\"><div id=\"saz-block-id-62058\" class=\"saz-block saz-block-core-image saz-block-id-array saz-block-width-400px saz-block-sizeslug-full saz-block-linkdestination-none saz-block-align-center\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n<figure class=\"aligncenter size-full is-resized\"><img decoding=\"async\" width=\"446\" height=\"570\" 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aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/it\/wp-json\/wp\/v2\/pages\/24576#wpcf7-f23133-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Modulo di contatto\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"23133\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.5\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"it_IT\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f23133-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7_recaptcha_response\" value=\"\" \/>\n<\/fieldset>\n<div class=\"agenda\">\n\t<h2>Registrati per scaricare l'articolo completo\n\t<\/h2>\n\t<p>Nome *<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"nome\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"nome\" \/><\/span><br \/>\nCognome *<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"cognome\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"cognome\" \/><\/span><br \/>\nAzienda<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"azienda\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text form-control\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"azienda\" \/><\/span><br \/>\nEmail *<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email form-control\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"email\" \/><\/span>\n\t<\/p>\n<\/div>\n<p>Come ci hai conosciuto *<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"Comecihaitrovato\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required form-control\" aria-required=\"true\" aria-invalid=\"false\" name=\"Comecihaitrovato\"><option value=\"Motori di ricerca (Google, Bing, ecc.)\">Motori di ricerca (Google, Bing, ecc.)<\/option><option value=\"Newsletter o Email\">Newsletter o Email<\/option><option value=\"Social Network (Facebook, Instagram, LinkedIn)\">Social Network (Facebook, Instagram, LinkedIn)<\/option><option value=\"Intelligenza artificiale (ChatGPT, Gemini, ecc.)\">Intelligenza artificiale (ChatGPT, Gemini, ecc.)<\/option><option value=\"Articoli di stampa\">Articoli di stampa<\/option><option value=\"Consiglio di amici o colleghi\">Consiglio di amici o colleghi<\/option><option value=\"Pubblicit\u00e0 online\">Pubblicit\u00e0 online<\/option><\/select><\/span>\n<\/p>\n<div class=\"checkbox-form\">\n\t<div class=\"d-flex\">\n\t\t<div class=\"checkbox-form has-extrasmall-font-size\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"privacy-consent\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><label><input type=\"checkbox\" name=\"privacy-consent\" value=\"1\" aria-invalid=\"false\" \/><span class=\"wpcf7-list-item-label\"><strong>Espressione del consenso al trattamento dei dati personali<\/strong><br>Autorizzo il trattamento dei dati personali da me conferiti per le finalit\u00e0 e nei limiti <a href=\"https:\/\/www.bonfiglioliconsulting.com\/it\/informativa-sulla-privacy\/\" target=\"_blank\" rel=\"noreferrer noopener\">indicati nell\u2019informativa<\/a>, conformemente a quanto previsto dall\u2019articolo 13 del Decreto Legislativo 30 giugno 2003, n. 196 (\u201cCodice in materia di protezione dei dati personali\u201d) e dall\u2019articolo 13 del Regolamento (UE) 2016\/679 (\u201cRegolamento Generale sulla Protezione dei Dati\u201d).<\/span><\/label><\/span><\/span><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"d-flex\">\n\t\t<div class=\"checkbox-form has-extrasmall-font-size\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"newsletter-consent\"><span class=\"wpcf7-form-control wpcf7-acceptance optional\"><span class=\"wpcf7-list-item\"><label><input type=\"checkbox\" name=\"newsletter-consent\" value=\"1\" aria-invalid=\"false\" \/><span class=\"wpcf7-list-item-label\"><strong>Consenso comunicazioni ed inviti (facoltativo)<\/strong><br>Acconsento a ricevere comunicazioni ed inviti da parte del Gruppo Bonfiglioli Consulting.<\/span><\/label><\/span><\/span><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n<input class=\"wpcf7-form-control wpcf7-hidden\" id=\"post_title\" value=\"\" type=\"hidden\" name=\"post_title\" \/>\n<input class=\"wpcf7-form-control wpcf7-hidden\" value=\"\" type=\"hidden\" name=\"submission_date\" \/>\n<input class=\"wpcf7-form-control wpcf7-hidden\" value=\"https:\/\/www.bonfiglioliconsulting.com\/wp-content\/uploads\/2024\/10\/Quality-By-Design-QbD-2.pdf\" type=\"hidden\" name=\"file\" \/>\n<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner btn btn-blu\" type=\"submit\" value=\"Download\" \/>\n<\/p><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-dYKz9b8Nbju4\" class=\"saz-block saz-block\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-CA4HFRHu0Z7p\" class=\"saz-block saz-block-core-paragraph\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n<p>Joseph Juran \u00e8 noto per la sua reinterpretazione della legge di Pareto, uno dei sette strumenti fondamentali della gestione della qualit\u00e0. Secondo Juran, infatti, occorre separare i &#8220;vital few&#8221; (le poche cose davvero importanti) dai &#8220;trivial many&#8221; (le molte cose meno importanti), nella gestione della qualit\u00e0. Tuttavia, il suo contributo pi\u00f9 significativo \u00e8 stato nell&#8217;ambito della gestione integrata della qualit\u00e0, alla base della struttura delle attuali norme ISO 9001.<strong> Sugger\u00ec un approccio strategico suddiviso in tre momenti chiave, definiti Quality Management Trilogy<\/strong>:<\/p>\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-1viW1X4atNiv\" class=\"saz-block saz-block\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-VwpVPFPbOQAU\" class=\"saz-block saz-block-core-list\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n<ul class=\"wp-block-list\"><div id=\"saz-block-id-ErMJ7ISvHweV\" class=\"saz-block saz-block-core-list-item\">\n<li>Qualiy Planning<\/li>\n<\/div>\n\n<div id=\"saz-block-id-rTAJPOne0rAn\" class=\"saz-block saz-block-core-list-item\">\n<li>Quality Control<\/li>\n<\/div>\n\n<div id=\"saz-block-id-pxWrYqUjuzAm\" class=\"saz-block saz-block-core-list-item\">\n<li>Quality Improvement.<\/li>\n<\/div><\/ul>\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-k246TgBmcfS2\" class=\"saz-block saz-block\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-94Rb8yZjtE7s\" class=\"saz-block saz-block-core-paragraph\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n<p><strong>Questo approccio sistematico permette alle organizzazioni di passare da una gestione delle emergenze (firefighting) a una gestione proattiva della qualit\u00e0<\/strong>, dove i piani di miglioramento dell\u2019efficienza operativa, come per esempio l\u2019Overall Equipment Effectiveness (OEE), sono integrati nel processo. Il processo diventa, quindi, intrinsecamente efficiente e quindi non necessita di essere costantemente monitorato.<\/p>\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-tL5fdAIaFq6X\" class=\"saz-block saz-block\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n\n<\/div><\/div><\/div><\/div><div id=\"saz-block-id-x3NZomLiionT\" class=\"saz-block saz-block-core-paragraph\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-lg-8 offset-lg-2\">\n<p>Nel contesto farmaceutico, l\u2019applicazione del <strong>Quality by Design<\/strong> ha acquisito particolare rilevanza a partire dal 2008, con la pubblicazione delle<strong> linee guida dell\u2019International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q8, Q9 e Q10<\/strong>. Le ICH invitano, infatti, le aziende farmaceutiche ad assicurarsi che la qualit\u00e0 del prodotto realizzato sia costante in maniera robusta. I prodotti devono essere garantiti nella qualit\u00e0, efficacia e sicurezza in base alle condizioni di processo e non perch\u00e9 controllati al 100%. Queste linee guida non fanno riferimento in maniera prescrittiva o diretta alle metodologie da applicare, lasciando alle aziende la facolt\u00e0 di scegliere il percorso migliore.<br><strong>L\u2019approccio Quality by Design e i suoi strumenti permettono una pianificazione e un controllo costante dei processi per progettare la qualit\u00e0 nativamente dal processo e, quindi, garantire la qualit\u00e0 del prodotto.<\/strong><\/p>\n<\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":null,"protected":false},"author":73,"featured_media":61298,"parent":23838,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-wide-blocchi.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-24576","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Quality by Design 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