{"id":310,"date":"2015-12-16T11:49:21","date_gmt":"2015-12-16T11:49:21","guid":{"rendered":"http:\/\/ingelyt.com\/cat\/?page_id=310"},"modified":"2016-07-01T07:48:32","modified_gmt":"2016-07-01T07:48:32","slug":"legislacio","status":"publish","type":"page","link":"https:\/\/ingelyt.com\/cat\/legislacio\/","title":{"rendered":"Legislaci\u00f3"},"content":{"rendered":"<p>S\u2019inclou la normativa m\u00e9s rellevant per al sector biosanitari (Farmac\u00e8utic, Veterinari, Bioseguretat, Cosm\u00e8tic o producte sanitari) de cara als requisits a complir en una instal\u00b7laci\u00f3, projecte o proc\u00e9s productiu. En cas de voler obtenir m\u00e9s detalls de la normativa en vigor d\u2019un sector determinat o si t\u00e9 dubtes en la seva interpretaci\u00f3 no dubti a posar-se en contacte amb nosaltres pharmasupport@ingelyt.com i l\u2019ajudarem en la interpretaci\u00f3. <\/p>\n<p>Tamb\u00e9 podem ajudar-lo a plantejar el seu projecte enfront de les ag\u00e8ncies reguladores m\u00e9s importants (AEMPS, EMA, FDA, Anvisa o qualsevol ag\u00e8ncia reguladora) per tal d\u2019aconseguir la revisi\u00f3 i vistiplau o aclarir qualsevol dubte davant les ag\u00e8ncies reguladores amb anterioritat o durant el projecte. <\/p>\n<p>Ingelyt garanteix que els projectes dissenyats i executats per part d\u2019Ingelyt compleixen amb la normativa en vigor de les diferents ag\u00e8ncies reguladores de cara a qu\u00e8 les instal\u00b7lacions siguin aprovades per diferents ag\u00e8ncies reguladores per als mercats amb majors exig\u00e8ncies. A m\u00e9s a m\u00e9s, pot realitzar tota la documentaci\u00f3 necess\u00e0ria per a la seva aprovaci\u00f3 (mem\u00f2ria t\u00e8cnica, Site Master File (SMF), qualificacions d\u2019instal\u00b7lacions i equipaments, pl\u00e0nols farmac\u00e8utics, an\u00e0lisi de riscos, protocols de validaci\u00f3 de proc\u00e9s, protocols de simulaci\u00f3 as\u00e8ptica (Media Fill).<\/p>\n<ol class=\"big\">\n<li><strong><a href=\"#unos\">Nomes de correcta fabricaci\u00f3 <\/a><\/strong><\/li>\n<li><strong><a href=\"#dos\">Normativa farmac\u00e8utica<\/a><\/strong><\/li>\n<li><strong><a href=\"#tres\">Legislaci\u00f3 productes est\u00e8rils<\/a><\/strong><\/li>\n<li><strong><a href=\"#cuatro\">Legislaci\u00f3 productes cosm\u00e8tics<\/a><\/strong><\/li>\n<li><strong><a href=\"#cinco\">Bioseguretat<\/a><\/strong><\/li>\n<\/ol>\n<h2 id=\"unos\">1. Nomes de correcta fabricaci\u00f3 <\/h2>\n<p>Les Normes de Correcta Fabricaci\u00f3 (NCF) o Good Manufacturing Practices (GMP) s\u00f3n les directrius fonamentals per tal de definir els est\u00e0ndards de qualitat en la fabricaci\u00f3 de medicaments. S\u00f3n d\u2019obligat compliment per a la ind\u00fastria farmac\u00e8utica. <\/p>\n<ul class=\"lower-alpha\">\n<li><strong>Europa (European Medicine Agency) (EMA)<\/strong>\n<ul>\n<li>Normes de correcta fabricaci\u00f3 AEMPS (Ag\u00e8ncia Espanyola del Medicament i Productes Sanitaris). Les normes de correcta fabricaci\u00f3 de la AEMPS s\u00f3n la transposici\u00f3 de la normativa europea en vigor<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>Normes de correcta fabricaci\u00f3 EMA (European Medicine Agency)<\/li>\n<li>EudraLex &#8211; Volume 4 Good manufacturing practice (GMP) Guidelines (EMA)<\/li>\n<li>Normes de correcta fabricaci\u00f3 comunes per a tots els pa\u00efsos europeus comunitaris<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>Estats Units d\u2019Am\u00e8rica (Food Drug administration) (FDA)<\/strong>\n<ul>\n<li>21 Code of Federal Regulations Part 210. 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. 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>Organizaci\u00f3n mundial de la salud (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. Normativa farmac\u00e8utica<\/h2>\n<p>La normativa farmac\u00e8utica internacional de m\u00e9s rellev\u00e0ncia cara als requisits internacionals a complir a les instal\u00b7lacions i fabricaci\u00f3 de medicaments <\/p>\n<ul class=\"lower-alpha\">\n<li>Les directrius ICH (Internacional Conference harmonization) s\u00f3n normes estandarditzades entres les ag\u00e8ncies reguladores m\u00e9s importants (Europa, FDA i Jap\u00f3) de cara a garantir unes normes de qualitat comunes\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>Organizaci\u00f3n mundial de la salud (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\">3. Legislaci\u00f3 de productes est\u00e8rils<\/h2>\n<p>Els productes est\u00e8rils, degut al risc que suposen per a l\u2019usuari final, tenen una normativa espec\u00edfica, la qual han de complir tots els fabricants<\/p>\n<p>La Normativa farmac\u00e8utica internacional m\u00e9s rellevant de cara als requisits internacionals a complir en la fabricaci\u00f3 de productes est\u00e8rils.<\/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\">4. Legislaci\u00f3 de productes cosm\u00e8tics<\/h3>\n<p>La fabricaci\u00f3 de productes cosm\u00e8tics t\u00e9 una legislaci\u00f3 espec\u00edfica per a les instal\u00b7lacions i processos de fabricaci\u00f3 de productes cosm\u00e8tics. <\/p>\n<ul class=\"circle\">\n<li><strong> cosm\u00e9ticos Guies FDA relatives a la fabricaci\u00f3 de cosm\u00e8tics<\/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\">5. Bioseguretat<\/h2>\n<p>La manipulaci\u00f3 de microorganismes vius exigeix uns requisits espec\u00edfics a les instal\u00b7lacions destinades a la seva manipulaci\u00f3, ja siguin centres d\u2019investigaci\u00f3 o laboratoris fabricants de medicaments d\u2019origen biol\u00f2gic. <\/p>\n<ul class=\"circle\">\n<li><strong>Guia T\u00e8cnica per a l\u2019avaluaci\u00f3 i prevenci\u00f3 dels riscos associats amb l\u2019exposici\u00f3 d\u2019agents biol\u00f2gics (INSHT del Ministeri de Treball)<\/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>Normativa de la CDC (Centers for disease control and prevention) dels Estats Units d\u2019Am\u00e8rica (USA) relativa als nivells de control per als diferents nivells de bioseguretat<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>Normativa canadenca (Laboratory Biosafety Guidelines)<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>Directrius de Bioseguretat de l\u2019Organitzaci\u00f3 Mundial de la Salut (OMS)<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>S\u2019inclou la normativa m\u00e9s rellevant per al sector biosanitari (Farmac\u00e8utic, Veterinari, Bioseguretat, Cosm\u00e8tic o producte sanitari) de cara als requisits a complir en una instal\u00b7laci\u00f3, projecte o proc\u00e9s productiu. En cas de voler obtenir m\u00e9s detalls de la normativa en [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"legislacion.php","meta":{"footnotes":""},"class_list":["post-310","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Legislaci\u00f3 - Enginyeria de sales blanques - Enginyeria de sales blanques - Consultoria Farmac\u00e8utica - Ingelyt<\/title>\n<meta name=\"description\" content=\"Ingelyt est\u00e0 format per professionals amb una alta qualificaci\u00f3 i experi\u00e8ncia en Legislaci\u00f3 per a la enginyeria e instal\u00b7laci\u00f3 de sales blanques i consultoria farmac\u00e8utica.\" \/>\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\/cat\/legislacio\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Legislaci\u00f3 - 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