{"id":1671,"date":"2015-01-13T13:16:02","date_gmt":"2015-01-13T13:16:02","guid":{"rendered":"http:\/\/ingelyt.com\/en\/?p=1671"},"modified":"2017-11-14T19:31:54","modified_gmt":"2017-11-14T19:31:54","slug":"good-manufacturing-practice-gmp-en-production-cosmetics","status":"publish","type":"post","link":"https:\/\/ingelyt.com\/en\/blog\/good-manufacturing-practices-gmp-production-cosmetics\/","title":{"rendered":"Good Manufacturing Practices (GMP) in the production of cosmetics"},"content":{"rendered":"<h2><b><strong>1. Introduction<\/strong><\/b><\/h2>\n<p>The requirements in the cosmetic sector are defined in the regulation of the CE N\u00ba 1223\/2009 of the European Parliament and of the Council about cosmetic products that was published in the Official Journal on December 22, 2009, that entered into force on January 11, 2010 and that is applicable sinde July 11, 2013.<\/p>\n<p><a href=\"https:\/\/www.boe.es\/doue\/2009\/342\/L00059-00209.pdf\">Download regulation (CE) No 1223\/2009<\/a><\/p>\n<h2><b><strong>2. Regulation 1223\/2009<\/strong><\/b><\/h2>\n<p>In this regulation the basic points are:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Definition and obligation of responsible person<\/li>\n<li>Content of the information file about the product<\/li>\n<li>Security evaluation of the medicines<\/li>\n<li>Prohibition of animal use for experimental purposes<\/li>\n<li>Restrictions for the use of certain substances<\/li>\n<li><b><strong>The manufacturing will be done within good manufacturing practices.\u00a0<\/strong><\/b><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><b><strong>3. GMP in the manufacturing of cosmetics<\/strong><\/b><\/h2>\n<p>For the compliance of the good manufacturing practices in the cosmetic field a regulation <strong>UNE-EN-ISO22716<\/strong> has been developed.<\/p>\n<p>This rule establishes the guidelines of good manufacturing practices in the production of cosmetic products according to the European Regulation bases, mainly focused on the managament of the factors related to the manufacturing of the products, with a view to eliminate and prevent deficiencies in the quality control. and its impact on the consumers.<\/p>\n<p>The regulation is structured in the following chapters \u00a0La norma se estructura en los siguientes cap\u00edtulos:<\/p>\n<p><strong>&#8211; <\/strong><em>Purpose and scope of application.<\/em><\/p>\n<p><em>&#8211; Terms\u00a0and Definitions.<\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Personnel. <\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Premises. <\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Equipments. <\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Raw materials \u00a0y Packaging Materials. <\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Production. <\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Finished products. <\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Quality Control Laboratory. <\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Product Treatment out of Specifications.<\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Wastes.<\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Types\u00a0of Subcontracts.<\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Deviations.<\/em><\/p>\n<p><strong>&#8211; <\/strong><em>\u00a0Claims and Market Withdrawals.<\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Exchange Control.<\/em><\/p>\n<p><strong>&#8211; <\/strong><em>Internal Audit.<\/em><\/p>\n<p><strong>&#8211; <\/strong><em>\u00a0Documentation<\/em><\/p>\n<p>The AEMPS will audit the plant againts this regulation and will emit a GMP certificate that englobes the following information.<\/p>\n<p><a href=\"http:\/\/ingelyt.com\/wp-content\/uploads\/2014\/11\/aemps.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-1679\" title=\"Buenas pr\u00e1cticas de fabricaci\u00f3n (GMP) en la fabricaci\u00f3n de cosm\u00e9ticos2\" src=\"http:\/\/ingelyt.com\/wp-content\/uploads\/2014\/11\/aemps.png\" alt=\"Buenas pr\u00e1cticas de fabricaci\u00f3n (GMP) en la fabricaci\u00f3n de cosm\u00e9ticos2\" width=\"573\" height=\"245\" \/><\/a><\/p>\n<h2><strong>4. <\/strong><b><strong>FDA\u00a0S<b><strong>tatus<\/strong><\/b><\/strong><\/b><\/h2>\n<p>The FDA has published the new\u00a0<strong><em>Good Manufacturing Practice Guide for Cosmetic Products<\/em><\/strong>\u00a0that include recommendations about documentation, storage, facilities and services, raw materials, processing and packaging, internal audits, laboratory controls, claim management and reports of adverse events, and the management of market withdrawals.<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/downloads\/Cosmetics\/GuidanceComplianceRegulatoryInformation\/GuidanceDocuments\/UCM358287.pdf\">Download Guidance for Cosmetic GMP<\/a><\/p>\n<p>This new document inspects the actual <strong><em>\u201cCosmetic Good Manufacturing (GMP) Guidelines\/Inspection Checklist\u201d,<\/em><\/strong>\u00a0and updates it to the current requirements of good practices.<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/Cosmetics\/GuidanceRegulation\/GuidanceDocuments\/ucm2005190.htm\">Download GMP Guidance\/Inspection checklist<\/a><\/p>\n<p>Additionally FDA tries to harmonise its requirements with those of the ISO 22716, despite that it includes only the relevant elements for its regulations and adds some others that are not included included in the ISO 22716. It also mentions the\u00a0Guidance for Industry on Cosmetics Processors and Transporters of Cosmetics Security Preventive Measures, which was revised in 2007.<\/p>\n<h2><b><strong>5. Ingelyt Support<\/strong><\/b><\/h2>\n<p>Ingelyt can realize in the cosmetic field a global solution that incorporates both adaptation of the facilities and the implementation of the quality system enshrined in the regulation UNE-EN-ISO 22716 for the GMP certification of the manufacturing plant by the health authorities both in Europe and the USA.<\/p>\n<p>If you wish the applicable regulation or a clarification about it, or any other additional information, feel free to contact us.<br \/>\nAlberto Carazo<\/p>\n<p>acarazo@ingelyt.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>1. Introduction The requirements in the cosmetic sector are defined in the regulation of the CE N\u00ba 1223\/2009 of the European Parliament and of the Council about cosmetic products that was published in the Official Journal on December 22, 2009, [&#8230;]<\/p>\n","protected":false},"author":3,"featured_media":2185,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[64],"tags":[],"class_list":["post-1671","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-support"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Good Manufacturing Practices (GMP) in the production of cosmetics - Ingelyt - Engineering and installations<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/ingelyt.com\/en\/blog\/good-manufacturing-practices-gmp-production-cosmetics\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Good Manufacturing Practices (GMP) in the production of cosmetics - Ingelyt - Engineering and installations\" \/>\n<meta property=\"og:description\" content=\"1. 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