{"id":4587,"date":"2019-06-06T15:38:52","date_gmt":"2019-06-06T18:38:52","guid":{"rendered":"http:\/\/passarini.com.br\/systems-validation-2\/"},"modified":"2021-10-19T16:57:08","modified_gmt":"2021-10-19T19:57:08","slug":"what-is-gmp","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/what-is-gmp\/","title":{"rendered":"What is GMP?"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias.webp\" alt=\"Informativos noticias\" width=\"1920\" height=\"500\" class=\"wp-image-6933\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2019\/06\/1920x500_informativos_noticias.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><p><strong>What is GMP?<\/strong><\/p>\n<p>GMP refers to the Good Manufacturing Practices Regulations defined by the Health Regulation and Health Surveillance Agencies of several countries. These regulations, which have the force of law, require manufacturers, processors and distributors of medicines, cosmetics, medical devices and food products to take proactive measures to ensure that their products are safe, pure and effective.<\/p>\n<p>GMP regulations require a quality approach to manufacturing, allowing companies to minimize or eliminate cases of contamination, mixtures and errors. These regulations protect the consumer from buying a product that is not effective or even dangerous. Failure by companies to comply with GMP regulations can result in very serious consequences, including recall, seizure, suspension of activities, fines and imprisonment.<\/p>\n<p>GMP regulations address issues such as maintenance and traceability of information; qualification of personnel; sanitation; cleaning; verification and qualification of equipment; validation of processes and systems; investigation and treatment of quality deviations and complaints.<\/p>\n<p>Most GMP requirements are very general and open, allowing each manufacturer to individually decide how best to implement the necessary controls. This provides a lot of flexibility, but also requires the manufacturer to interpret the requirements in a way that makes sense for each individual business. In addition, manufacturers should employ technologies and systems that are up to date to comply with the regulation.<\/p>\n<p>It is important to emphasize that cGMPs regulations are minimum requirements. Many manufacturers of pharmaceuticals and medical devices are already implementing comprehensive and modern quality systems and risk management approaches that exceed these minimum standards.<\/p>\n<p>Talk to our consultants about your need, we do GMP auditing anywhere in the world.<\/p>\n<p>For more information and explanations about it, send us an e-mail:<span style=\"color: #0000ff;\">\u00a0<strong><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>Passarini Regulatory Affairs<\/strong><\/span><\/p>\n<\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-floated\" style=\"background-color:#f6f6f6;--awb-layout:row;--awb-alignment-small:space-between;\" data-title=\"Passarini Regulatory Affairs\" data-description=\"What is GMP?\r\nGMP refers to the Good Manufacturing Practices Regulations defined by the Health Regulation and Health Surveillance Agencies of several countries. 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":4582,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67,68,73,167,159],"tags":[70,154,190,155,149],"class_list":["post-4587","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-brazil","category-cheers","category-gmp-2","category-regulatory","tag-brazil","tag-cheers","tag-gmp-en","tag-health","tag-regulatory"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4587","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=4587"}],"version-history":[{"count":11,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4587\/revisions"}],"predecessor-version":[{"id":7456,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4587\/revisions\/7456"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/4582"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=4587"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=4587"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=4587"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}