{"id":4284,"date":"2017-07-19T09:31:55","date_gmt":"2017-07-19T07:31:55","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=4284\/"},"modified":"2017-07-19T09:31:55","modified_gmt":"2017-07-19T07:31:55","slug":"cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/","title":{"rendered":"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP?"},"content":{"rendered":"<p>The design is excluded for some class I devices or when it is carried out by other subject responsible for it. If a manufacturer is responsible for some operations subject only to the 21 CFR 820 requirements (for example, if he acts as a Contract Manufacturer), he should only meet the requirements applicable to the activities of which he is in charge.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The design is excluded for some class I devices or when it is carried out by other subject responsible for it.  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[892,1552],"tags":[],"class_list":["post-4284","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-what-are-the-gmp-requirements-faq-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>cGMp FDA: when can I exclude the design from my quality system according to the US cGMP? - Thema Med<\/title>\n<meta name=\"description\" content=\"The design is excluded for some class I devices or when it is carried out by other subject responsible for it. If a manufacturer is responsible for some...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP? - Thema Med\" \/>\n<meta property=\"og:description\" content=\"The design is excluded for some class I devices or when it is carried out by other subject responsible for it. If a manufacturer is responsible for some...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema Med\" \/>\n<meta property=\"article:published_time\" content=\"2017-07-19T07:31:55+00:00\" \/>\n<meta name=\"author\" content=\"redazione\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"redazione\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/\"},\"author\":{\"name\":\"redazione\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\"},\"headline\":\"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP?\",\"datePublished\":\"2017-07-19T07:31:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/\"},\"wordCount\":77,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"articleSection\":[\"FAQ\",\"What are the GMP requirements?\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/\",\"url\":\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/\",\"name\":\"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP? - Thema Med\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\"},\"datePublished\":\"2017-07-19T07:31:55+00:00\",\"description\":\"The design is excluded for some class I devices or when it is carried out by other subject responsible for it. If a manufacturer is responsible for some...\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"http:\/\/www.thema-med.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"name\":\"Thema Med\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\",\"name\":\"redazione\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"caption\":\"redazione\"},\"sameAs\":[\"http:\/\/www.thema-med.eu\"],\"url\":\"https:\/\/www.thema-med.com\/en\/author\/emanuele\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP? - Thema Med","description":"The design is excluded for some class I devices or when it is carried out by other subject responsible for it. If a manufacturer is responsible for some...","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/","og_locale":"en_US","og_type":"article","og_title":"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP? - Thema Med","og_description":"The design is excluded for some class I devices or when it is carried out by other subject responsible for it. If a manufacturer is responsible for some...","og_url":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/","og_site_name":"Thema Med","article_published_time":"2017-07-19T07:31:55+00:00","author":"redazione","twitter_card":"summary_large_image","twitter_misc":{"Written by":"redazione"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/#article","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/"},"author":{"name":"redazione","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e"},"headline":"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP?","datePublished":"2017-07-19T07:31:55+00:00","mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/"},"wordCount":77,"publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"articleSection":["FAQ","What are the GMP requirements?"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/","url":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/","name":"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP? - Thema Med","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/#website"},"datePublished":"2017-07-19T07:31:55+00:00","description":"The design is excluded for some class I devices or when it is carried out by other subject responsible for it. If a manufacturer is responsible for some...","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"http:\/\/www.thema-med.com\/en\/"},{"@type":"ListItem","position":2,"name":"cGMp FDA: when can I exclude the design from my quality system according to the US cGMP?"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/en\/#website","url":"https:\/\/www.thema-med.com\/en\/","name":"Thema Med","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/en\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e","name":"redazione","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","caption":"redazione"},"sameAs":["http:\/\/www.thema-med.eu"],"url":"https:\/\/www.thema-med.com\/en\/author\/emanuele\/"}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/4284","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/comments?post=4284"}],"version-history":[{"count":0,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/4284\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/media?parent=4284"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/categories?post=4284"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/tags?post=4284"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}