{"id":1653,"date":"2015-10-20T18:30:53","date_gmt":"2015-10-20T22:30:53","guid":{"rendered":"https:\/\/www.ropack.com\/?p=1653"},"modified":"2025-07-02T15:51:59","modified_gmt":"2025-07-02T19:51:59","slug":"une-approche-economique-a-la-validation-et-a-la-verification-des-procedes-de-nettoyage","status":"publish","type":"post","link":"https:\/\/www.ropack.com\/fr\/une-approche-economique-a-la-validation-et-a-la-verification-des-procedes-de-nettoyage\/","title":{"rendered":"Une approche \u00e9conomique \u00e0 la validation et \u00e0 la v\u00e9rification des proc\u00e9d\u00e9s de nettoyage"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-1803 alignleft\" src=\"\/wp-content\/uploads\/2015\/10\/AI_Image-1024x696.jpg\" alt=\"AI_Image\" width=\"273\" height=\"192\" \/><\/p>\n<h2>Alexander Wellems<br \/>\ndirecteur de la fabrication, Ropack Pharma Solutions<\/h2>\n<p>&nbsp;<\/p>\n<p>Une organisation de fabrication \u00e0 forfait qui offre des services complets traite de nombreux compos\u00e9s chimiques \u00e0 diff\u00e9rentes \u00e9tapes de d\u00e9veloppement, en plus de r\u00e9pondre aux exigences vari\u00e9es de ses divers clients. Que ce soit pour une fabrication \u00e0 grande \u00e9chelle et pleinement d\u00e9velopp\u00e9e ou pour un seul lot de d\u00e9veloppement, l\u2019organisation doit \u00eatre pr\u00eate \u00e0 manipuler plusieurs compos\u00e9s dans la m\u00eame installation. Une exigence extr\u00eamement importante consiste \u00e0 s\u2019assurer que les proc\u00e9d\u00e9s de nettoyage \u00e9tablis enl\u00e8vent tous les r\u00e9sidus de principes actifs des pi\u00e8ces d\u2019\u00e9quipement venant en contact direct avec le produit et utilis\u00e9es pendant la fabrication, de sorte qu\u2019il n\u2019y ait aucun risque de contamination crois\u00e9e.<\/p>\n<p>La FDA pr\u00e9sente clairement ses attentes dans le document <em>Validation of Cleaning Processes<\/em>, sous la rubrique <em>Inspections Guides<\/em>. Pour r\u00e9pondre aux attentes qui y sont \u00e9num\u00e9r\u00e9es, plusieurs approches de v\u00e9rification et de validation des proc\u00e9d\u00e9s de nettoyage sont possibles, et le sous-traitant doit d\u00e9terminer l\u2019approche la plus efficace, la plus \u00e9conomique et la plus pratique. Dans un contexte de sous-traitance, l\u2019approche courante de validation de trois lots n\u2019est probablement pas la plus pratique, car trois lots cons\u00e9cutifs ne seront peut-\u00eatre jamais fabriqu\u00e9s d\u2019un seul coup. De plus, m\u00eame si la v\u00e9rification de chaque lot fabriqu\u00e9 peut \u00eatre envisag\u00e9e (car elle suffirait \u00e0 garantir l\u2019absence de r\u00e9sidus de principes actifs et de d\u00e9tergents), elle ne constituerait pas l\u2019approche la plus \u00e9conomique, parce qu\u2019elle n\u00e9cessiterait une grande quantit\u00e9 d\u2019analyses d\u2019\u00e9chantillons et entra\u00eenerait des hausses \u00e9videntes des co\u00fbts de laboratoire.<\/p>\n<p>Une approche ax\u00e9e sur les risques et qui s\u2019appuie sur le pire des sc\u00e9narios est la plus appropri\u00e9e pour une organisation de fabrication \u00e0 forfait. En utilisant un compos\u00e9 connu \u00e0 faible solubilit\u00e9 et \u00e0 faible puissance sur l\u2019\u00e9quipement le plus \u00e0 risque et sur les zones les plus \u00e0 risque de l\u2019\u00e9quipement, un protocole de validation peut \u00eatre mis au point pour garantir l\u2019enl\u00e8vement des principes actifs. Toutes les consid\u00e9rations pr\u00e9sent\u00e9es dans le guide d\u2019inspection de la FDA doivent \u00eatre respect\u00e9es, incluant l\u2019\u00e9valuation de la conception de l\u2019\u00e9quipement, les proc\u00e9dures \u00e9crites et reproductibles de nettoyage et d\u2019\u00e9chantillonnage, les m\u00e9thodes d\u2019analyse valid\u00e9es et les crit\u00e8res d\u2019acceptation \u00e9tablis.<\/p>\n<p>Apr\u00e8s l&rsquo;\u00e9laboration du protocole de validation, une grille et un processus ax\u00e9s sur les risques doivent \u00eatre cr\u00e9\u00e9s. Tous les nouveaux compos\u00e9s doivent \u00eatre \u00e9valu\u00e9s en s\u2019appuyant sur cette grille, qui couvre \u00e9galement tous les excipients et l\u2019\u00e9quipement \u00e0 utiliser. Si un nouveau compos\u00e9 chimique pr\u00e9sente des risques plus \u00e9lev\u00e9s que le compos\u00e9 ayant \u00e9t\u00e9 initialement v\u00e9rifi\u00e9, un nouveau protocole de validation doit \u00eatre \u00e9tabli et utilis\u00e9 avec le nouveau compos\u00e9.<\/p>\n<p>Gr\u00e2ce \u00e0 une approche de v\u00e9rification et de validation des proc\u00e9d\u00e9s de nettoyage qui s\u2019appuie sur une grille ax\u00e9e sur les risques et sur le pire des sc\u00e9narios, une organisation de fabrication \u00e0 forfait peut r\u00e9pondre \u00e0 toutes les exigences r\u00e9glementaires et aux normes BPF tout en poursuivant des activit\u00e9s all\u00e9g\u00e9es et \u00e9conomiques.<\/p>\n<p style=\"text-align: left;\">R\u00e9f\u00e9rences :<br \/>\n<em>Guides d\u2019inspection de la FDA \u2013 Validation of Cleaning Processes. <\/em><br \/>\n<a href=\"http:\/\/www.fda.gov\/ICECI\/Inspections\/InspectionGuides\/ucm074922.htm\">http:\/\/www.fda.gov\/ICECI\/Inspections\/InspectionGuides\/ucm074922.htm<\/a><\/p>\n<p style=\"text-align: left;\"><em>Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants.<\/em> <a href=\"http:\/\/apic.cefic.org\/pub\/pub-cleaning-validation.pdf\">http:\/\/apic.cefic.org\/pub\/pub-cleaning-validation.pdf<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Alex Wellems<\/strong> est directeur de la fabrication chez Ropack Pharma Solutions, qui soutient <a href=\"https:\/\/www.ropack.com\/fr\/2016\/04\/18\/comment-reussir-le-transfert-des-methodes-analytiques-pour-votre-forme-orale-solide-en-trois-etapes\/\"  data-wpil-monitor-id=\"24\">les projets de formes orales solides<\/a> depuis la formulation initiale et la fabrication, l\u2019emballage et la distribution cliniques jusqu\u2019\u00e0 la fabrication et l\u2019emballage commerciaux. Il travaille depuis plus de 13 ans dans le secteur du d\u00e9veloppement de m\u00e9dicaments, se consacrant plus particuli\u00e8rement <a href=\"https:\/\/www.ropack.com\/fr\/services\/materiel-essai-clinique\/\"  data-wpil-monitor-id=\"25\">\u00e0 la pr\u00e9paration d\u2019essais cliniques<\/a> et au transfert de technologie. Il poss\u00e8de un baccalaur\u00e9at en g\u00e9nie chimique de l\u2019Universit\u00e9 Case Western Reserve.<\/p>\n<p><img decoding=\"async\" class=\"size-full wp-image-1902 alignleft\" src=\"https:\/\/www.ropack.com\/wp-content\/uploads\/2015\/10\/alexander-wellems_ropack.png\" alt=\"alexander wellems_ropack\" width=\"202\" height=\"202\" \/><\/p>\n<p>&nbsp;<\/p>\n<p><strong>ALEXANDER WELLEMS<\/strong><br \/>\nDirecteur de la fabrication, Ropack Pharma Solutions<br \/>\n<a href=\"mailto:alexander.wellems@ropack.com\">\u00c9crivez \u00e0\u00a0Alexander Wellems<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Alexander Wellems directeur de la fabrication, Ropack Pharma Solutions &nbsp; Une organisation de fabrication \u00e0 forfait qui offre des services complets traite de nombreux compos\u00e9s chimiques \u00e0 diff\u00e9rentes \u00e9tapes de d\u00e9veloppement, en plus de r\u00e9pondre aux exigences vari\u00e9es de ses divers clients. Que ce soit pour une fabrication \u00e0 grande \u00e9chelle et pleinement d\u00e9velopp\u00e9e ou [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":1311,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[36,46,45],"tags":[],"class_list":["post-1653","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-fr","category-fournitures-cliniques","category-fabrication-emballage"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Validation nettoyage : m\u00e9thode \u00e9conomique<\/title>\n<meta name=\"description\" content=\"D\u00e9couvrez une approche rentable et conforme pour valider et v\u00e9rifier vos proc\u00e9d\u00e9s de nettoyage dans l&#039;industrie pharmaceutique.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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