{"id":31,"date":"2014-06-19T17:02:59","date_gmt":"2014-06-19T17:02:59","guid":{"rendered":"http:\/\/ingelyt.com\/?page_id=31"},"modified":"2014-07-29T15:43:28","modified_gmt":"2014-07-29T15:43:28","slug":"legislacion","status":"publish","type":"page","link":"http:\/\/ingelyt.com\/fr\/legislation\/","title":{"rendered":"L\u00e9gislation"},"content":{"rendered":"<p>Est incluse la r\u00e9glementation la plus \u00e9minente pour le secteur biosanitaire (le Pharmacien, le V\u00e9t\u00e9rinaire, la Bios\u00e9curit\u00e9, Cosm\u00e9tique ou un produit sanitaire) pour des requ\u00eates auxquelles doivent satisfaire dans une installation, un projet ou un processus productif. Dans le cas on est int\u00e9ress\u00e9 \u00e0 avoir un plus grand d\u00e9tail de la r\u00e9glementation en vigueur d&rsquo;un secteur ou qui a des doutes dans son interpr\u00e9tation n&rsquo;h\u00e9sitez pas \u00e0 nous contacter: pharmasupport@ingelyt.com nous vous aiderons \u00e0 son interpr\u00e9tation.<\/p>\n<p>Nous pouvons aider \u00e0 projeter aussi son projet devant les agences r\u00e9gulatoires les plus importantes (AEMPS, EMA, FDA, Anvisa ou tout organisme de r\u00e9glementation) pour obtenir la r\u00e9vision et approbation ou clarifier tous les doutes devant les agences r\u00e9gulatoires avant ou pendant le projet.<\/p>\n<p>Ingelyt garantit que les projets con\u00e7us et mis en \u0153uvre par nous sont conformes \u00e0 la r\u00e9glementation en vigueur des divers agences r\u00e9gulatoires de sorte que les installations sont approuv\u00e9es par les agences r\u00e9gulatoires pour les march\u00e9s de plus grandes requ\u00eates, en pouvant r\u00e9aliser toute la documentation requise pour son approbation (m\u00e9moire technique, Site Master File (SMF), des qualifications d&rsquo;installations et d&rsquo;\u00e9quipes, de plans pharmaceutiques, analyse de risques, des protocoles de validation de processus, des protocoles de simulation aseptique (la Moyenne Fill), \u2026.)<\/p>\n<ol class=\"big\">\n<li><strong><a href=\"#unos\">Bonnes Pratiques de fabrication (BPF)<\/a><\/strong><\/li>\n<li><strong><a href=\"#dos\">Normativa farmac\u00e9utica<\/a><\/strong><\/li>\n<li><strong><a href=\"#tres\">Legislaci\u00f3n productos est\u00e9riles<\/a><\/strong><\/li>\n<li><strong><a href=\"#cuatro\">Legislaci\u00f3n productos cosm\u00e9ticos<\/a><\/strong><\/li>\n<li><strong><a href=\"#cinco\">Bioseguridad<\/a><\/strong><\/li>\n<\/ol>\n<h2 id=\"unos\">1. Bonnes Pratiques de fabrication (BPF)<\/h2>\n<p>Les bonnes pratiques de fabrication (BPF) ou Good Manufacturing Practices (GMP) sont les lignes directrices de base pour la d\u00e9finition de normes de qualit\u00e9 dans la fabrication de m\u00e9dicaments. Ils sont obligatoires pour l&rsquo;industrie pharmaceutique.<\/p>\n<ul class=\"lower-alpha\">\n<li><strong>Europa (European Medicine Agency)(EMA)<\/strong>\n<ul>\n<li>Bonnes pratiques de fabrication AEMPS (Agencia Espa\u00f1ola del Medicamento y Productos Sanitarios)<br \/>\nLes bonnes pratiques de fabrication de l&rsquo;AEMPS est la transposition de la r\u00e9glementation europ\u00e9enne en vigueur.<br \/>\n<a href=\"http:\/\/www.aemps.gob.es\/industria\/inspeccionNCF\/guiaNCF\/home.htm\" target=\"_blank\">http:\/\/www.aemps.gob.es\/industria\/inspeccionNCF\/guiaNCF\/home.htm<\/a><\/li>\n<li>Bonne pratiques de fabrication EMA (European Medicine Agency)<\/li>\n<li>EudraLex &#8211; Volume 4 Good manufacturing practice (GMP) Guidelines (EMA)<\/li>\n<li>Les bonnes pratiques de fabrication commun \u00e0 tous les pays de l&rsquo;UE<br \/>\n<a href=\"http:\/\/ec.europa.eu\/health\/documents\/eudralex\/vol-4\/index_en.htm\" target=\"_blank\">http:\/\/ec.europa.eu\/health\/documents\/eudralex\/vol-4\/index_en.htm<\/a><\/li>\n<\/ul>\n<\/li>\n<li><strong>\u00c9tats Unis d&rsquo;Am\u00e9rique (Food Drug administration) (FDA)<\/strong>\n<ul>\n<li>21 Code of Federal Regulations Part 210.\u00a0 Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs<br \/>\n<a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=210.1\" target=\"_blank\">http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=210.1<\/a><\/li>\n<li>21 Code of Federal Regulations Part 211.\u00a0 Current Good Manufacturing Practice for Finished Pharmaceuticals<br \/>\n<a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=211\" target=\"_blank\">http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=211<\/a><\/li>\n<\/ul>\n<\/li>\n<li><strong>Organisation mondiale de la sant\u00e9 (OMS\/WHO)<\/strong>\n<ul>\n<li><a href=\"http:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/GMPPharmaceuticalProductsMainPrinciplesTRS961Annex3.pdf?ua=1\" target=\"_blank\">http:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/GMPPharmaceuticalProductsMainPrinciplesTRS961Annex3.pdf?ua=1<\/a><\/li>\n<\/ul>\n<\/li>\n<li><strong>PIC\/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme )<\/strong>\n<ul>\n<li>PIC\/S GMP Guide<a href=\"http:\/\/www.picscheme.org\/publication.php?id=4\" target=\"_blank\">http:\/\/www.picscheme.org\/publication.php?id=4<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2 id=\"dos\">2. L\u00e9gislation pharmaceutique<\/h2>\n<p>R\u00e9glementation pharmaceutique internationale plus \u00e9minente pour s&rsquo;acquitter \u00e0 des exigencies internationales dans les installations et la fabrication de medicaments.<\/p>\n<ul class=\"lower-alpha\">\n<li><strong>ICH (International Conference harmonization)<\/strong><br \/>\nLes guidelines ICH (International Conference harmonization) sont normes standardis\u00e9es entre les agences r\u00e9gulatoires les plus importantes (l&rsquo;Europe, FDA et le Japon) pour garantir quelques normes communes de qualit\u00e9.<\/p>\n<ul>\n<li>Q7 Good manufacturing practice guide for active pharmaceutical ingredients<br \/>\n<a href=\"http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Quality\/Q7\/Step4\/Q7_Guideline.pdf\" target=\"_blank\">http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Quality\/Q7\/Step4\/Q7_Guideline.pdf<\/a><\/li>\n<li>Q9 Quality risk management<br \/>\n<a href=\"http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Quality\/Q9\/Step4\/Q9_Guideline.pdf\" target=\"_blank\">http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Quality\/Q9\/Step4\/Q9_Guideline.pdf<\/a><\/li>\n<\/ul>\n<\/li>\n<li><strong>PIC\/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme)<\/strong>\n<ul>\n<li><a href=\"http:\/\/www.picscheme.org\/publication.php?id=4\" target=\"_blank\">http:\/\/www.picscheme.org\/publication.php?id=4<\/a><\/li>\n<li>Explanatory notes for pharmaceutical manufacturers on the preparation of a site master file PE 008-4<\/li>\n<li>Validation master plan installation and operational qualification non-sterile process<\/li>\n<li>Validation cleaning validation PI 006-3<\/li>\n<li>Validation of aseptic processes PI 007-6<\/li>\n<\/ul>\n<\/li>\n<li><strong>Organisation Mondiale de la Sant\u00e9 (OMS\/WHO)<\/strong>\n<ul>\n<li>Inspections guidelines<br \/>\n<a href=\"http:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/inspections\/en\" target=\"_blank\">http:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/inspections\/en<\/a><\/li>\n<li>Production guidelines<br \/>\n<a href=\"http:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/production\/en\/\" target=\"_blank\">http:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/production\/en\/<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2 id=\"tres\">L\u00e9gislation de produits st\u00e9riles<\/h2>\n<p>Les produits st\u00e9riles par le risque qu&rsquo;ils supposent pour l&rsquo;utilisateur final ont une r\u00e9glementation sp\u00e9cifique qui doit \u00eatre accomplie par les diff\u00e9rents fabricants.<\/p>\n<p>La R\u00e9glementation pharmaceutique internationale la plus \u00e9minente pour s&rsquo;acquitter \u00e0 des exigences internationales dans la fabrication de produits st\u00e9riles.<\/p>\n<ul class=\"circle\">\n<li><strong>Eudralex Vol. 4 (EU GMP) Annex 1 \u201cGuideline for the manufacture of sterile medicine products.\u201d<\/strong><br \/>\n<a href=\"http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-4\/2008_11_25_gmp-an1_en.pdf\" target=\"_blank\">http:\/\/ec.europa.eu\/health\/files\/eudralex\/vol-4\/2008_11_25_gmp-an1_en.pdf<\/a><\/li>\n<li><strong>PICS PI007-6 Recommendation on the validation of septic processes<\/strong><br \/>\n<a href=\"http:\/\/www.picscheme.org\/pdf\/26_pi007-6recommendationonasepticprocesses.pdf\" target=\"_blank\">http:\/\/www.picscheme.org\/pdf\/26_pi007-6recommendationonasepticprocesses.pdf<\/a><\/li>\n<li><strong>FDA Guidance sterile drug products produced by aseptic processes<\/strong><br \/>\n<a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/...\/Guidances\/ucm070342.pdf\" target=\"_blank\">http:\/\/www.fda.gov\/downloads\/Drugs\/&#8230;\/Guidances\/ucm070342.pdf<\/a><\/li>\n<li><strong>ISO13408 Aseptic processing of health care products general requeriments<\/strong><br \/>\n<a href=\"http:\/\/www.iso.org\/iso\/search.htm?qt=13408&amp;sort_by=rel&amp;type=simple&amp;published=on&amp;active_tab=standards\" target=\"_blank\">http:\/\/www.iso.org\/iso\/search.htm?qt=13408&amp;sort_by=rel&amp;type=simple&amp;published=on&amp;active_tab=standards<\/a><\/li>\n<li><strong>PDA TR N\u00ba 28 : process simulation testing for sterile bulk pharmaceutical chemicals <\/strong><br \/>\n<a href=\"https:\/\/store.pda.org\/TableOfContents\/PDA_Technical_Reports_list.pdf\" target=\"_blank\">https:\/\/store.pda.org\/TableOfContents\/PDA_Technical_Reports_list.pdf<\/a><\/li>\n<li><strong>PDA TR N\u00ba44 : Quality risk management for aseptic processes (2008)<\/strong><br \/>\n<a href=\"https:\/\/store.pda.org\/TableOfContents\/PDA_Technical_Reports_list.pdf\" target=\"_blank\">https:\/\/store.pda.org\/TableOfContents\/PDA_Technical_Reports_list.pdf<\/a><\/li>\n<li><strong>PDA TR N\u00ba22 Process simulation for aseptically filled products (2011)<\/strong><br \/>\n<a href=\"https:\/\/store.pda.org\/TableOfContents\/PDA_Technical_Reports_list.pdf\" target=\"_blank\">https:\/\/store.pda.org\/TableOfContents\/PDA_Technical_Reports_list.pdf<\/a><\/li>\n<li><strong>PDA TR N62 : Recommended practices for manual aseptic processes<\/strong><br \/>\n<a href=\"https:\/\/store.pda.org\/TableOfContents\/PDA_Technical_Reports_list.pdf\" target=\"_blank\">https:\/\/store.pda.org\/TableOfContents\/PDA_Technical_Reports_list.pdf<\/a><\/li>\n<\/ul>\n<h3 id=\"cuatro\">L\u00e9gislation des produits cosm\u00e9tiques<\/h3>\n<p>La fabrication de produits cosm\u00e9tiques a une l\u00e9gislation sp\u00e9cifique pour les installations et les processus de fabrication de produits cosm\u00e9tiques.<\/p>\n<ul class=\"circle\">\n<li><strong>Des guides FDA relatif \u00e0 une fabrication de cosm\u00e9tiques<\/strong><br \/>\n<a href=\"http:\/\/www.fda.gov\/Cosmetics\/GuidanceRegulation\/GuidanceDocuments\/default.htm\" target=\"_blank\">http:\/\/www.fda.gov\/Cosmetics\/GuidanceRegulation\/GuidanceDocuments\/default.htm<\/a><\/li>\n<li><strong>Regulation (EC) No 1223\/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products<\/strong><br \/>\n<a href=\"http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF\" target=\"_blank\">http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF<\/a><\/li>\n<li><strong>ISO 22716:2007 Cosmetics GMP<\/strong><br \/>\n<a href=\"http:\/\/www.iso.org\/iso\/catalogue_detail.htm?csnumber=36437\" target=\"_blank\">http:\/\/www.iso.org\/iso\/catalogue_detail.htm?csnumber=36437<\/a><\/li>\n<\/ul>\n<h2 id=\"cinco\">Bios\u00e9curit\u00e9<\/h2>\n<p>La manipulation des organismes vivants n\u00e9cessite des exigences sp\u00e9cifiques dans les installations destin\u00e9es \u00e0 sa manipulation soyez centres de recherche ou de laboratoires des fabricants de m\u00e9dicaments d&rsquo;origine biologique.<\/p>\n<ul class=\"circle\">\n<li><strong>Guide technique pour l&rsquo;\u00e9valuation et la pr\u00e9vention des risques li\u00e9s \u00e0 l&rsquo;exposition \u00e0 des agents biologiques (INSHT del Ministerio de Trabajo)<\/strong><br \/>\n<a href=\"http:\/\/www.insht.es\/InshtWeb\/Contenidos\/Normativa\/GuiasTecnicas\/Ficheros\/agen_bio.pdf\" target=\"_blank\">http:\/\/www.insht.es\/InshtWeb\/Contenidos\/Normativa\/GuiasTecnicas\/Ficheros\/agen_bio.pdf<\/a><\/li>\n<li><strong>R\u00e8glement des CDC (Centers for disease control and prevention) des Etats-Unis d&rsquo;Am\u00e9rique (USA) concernant les niveaux de contr\u00f4le pour les diff\u00e9rents niveaux de bios\u00e9curit\u00e9<\/strong><br \/>\n<a href=\"http:\/\/www.cdc.gov\/biosafety\/publications\/bmbl5\/bmbl5_sect_iv.pdf\" target=\"_blank\">http:\/\/www.cdc.gov\/biosafety\/publications\/bmbl5\/bmbl5_sect_iv.pdf<\/a><\/li>\n<li><strong>R\u00e8glement canadien (Laboratory Biosafety Guidelines)<\/strong><br \/>\n<a href=\"http:\/\/www.phac-aspc.gc.ca\/publicat\/lbg-ldmbl-04\/index-eng.php\" target=\"_blank\">http:\/\/www.phac-aspc.gc.ca\/publicat\/lbg-ldmbl-04\/index-eng.php<\/a><\/li>\n<li><strong>Lignes directrices en mati\u00e8re de bios\u00e9curit\u00e9 de l&rsquo;Organisation mondiale de la Sant\u00e9 (OMS), 2003<\/strong><br \/>\n<a href=\"http:\/\/www.who.int\/csr\/resources\/publications\/biosafety\/CDS_CSR_LYO_2004_11SP.pdf\" target=\"_blank\">http:\/\/www.who.int\/csr\/resources\/publications\/biosafety\/CDS_CSR_LYO_2004_11SP.pdf<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Est incluse la r\u00e9glementation la plus \u00e9minente pour le secteur biosanitaire (le Pharmacien, le V\u00e9t\u00e9rinaire, la Bios\u00e9curit\u00e9, Cosm\u00e9tique ou un produit sanitaire) pour des requ\u00eates auxquelles doivent satisfaire dans une installation, un projet ou un processus productif. Dans le cas [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":1185,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"legislacion.php","meta":{"footnotes":""},"class_list":["post-31","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>L\u00e9gislation - Ing\u00e9nierie de salles blanches - Ingelyt - Ing\u00e9nierie et installations<\/title>\n<meta name=\"description\" content=\"\u00c0 Ingelyt nous sommes des professionnels avec une haute qualification et exp\u00e9rience en L\u00e9gislation pour l&#039;ing\u00e9nierie d&#039;installation de salles blanches et conseil pharmaceutique.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ingelyt.com\/fr\/legislation\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"L\u00e9gislation - 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