{"id":357,"date":"2016-08-13T12:52:17","date_gmt":"2016-08-13T02:52:17","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=357"},"modified":"2020-07-29T14:38:25","modified_gmt":"2020-07-29T03:38:25","slug":"notes-on-usp36-nf31","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2016\/08\/13\/notes-on-usp36-nf31\/","title":{"rendered":"Notes on USP36-NF31 <1116 - Microbiological Evaluation of Cleanrooms and Other Controlled Environments>"},"content":{"rendered":"<p>The USP is the United State&#8217;s Pharmacopeia.<\/p>\n<p>If you are selling pharmaceuticals in the USA, you need to follow the USP and are subject to FDA regulation.\u00a0 For the layperson, a pharmacopeia is an official publication containing a list of medicinal drugs with their effects and directions for their manufacturing, testing and use.<\/p>\n<p>The latest iteration of this section of the USP is 39-NF34,\u00a0 The last version I managed to get my hands on was USP36 NF31.\u00a0 I&#8217;ve compared the two and noted the changes from the <a href=\"http:\/\/paulyeatman.net.au\/index.php\/2009\/08\/11\/notes-on-usp31-nf26\/\" target=\"_blank\" rel=\"noopener\">NF I reviewed initially.<\/a>\u00a0 The identified changes are in blue.<!--more--><\/p>\n<p>Same as other post, but with changes.<\/p>\n<p><span style=\"border-radius: 2px; text-indent: 20px; width: auto; padding: 0px 4px 0px 0px; text-align: center; font: bold 11px\/20px 'Helvetica Neue',Helvetica,sans-serif; color: #ffffff; background: #bd081c no-repeat scroll 3px 50% \/ 14px 14px; position: absolute; opacity: 1; z-index: 8675309; display: none; cursor: pointer;\">Save<\/span><\/p>\n<p><span style=\"border-radius: 2px; text-indent: 20px; width: auto; padding: 0px 4px 0px 0px; text-align: center; font: bold 11px\/20px 'Helvetica Neue',Helvetica,sans-serif; color: #ffffff; background: #bd081c no-repeat scroll 3px 50% \/ 14px 14px; position: absolute; opacity: 1; z-index: 8675309; display: none; cursor: pointer;\">Save<\/span><\/p>\n<p><span style=\"border-radius: 2px; text-indent: 20px; width: auto; padding: 0px 4px 0px 0px; text-align: center; font: bold 11px\/20px 'Helvetica Neue',Helvetica,sans-serif; color: #ffffff; background: #bd081c no-repeat scroll 3px 50% \/ 14px 14px; position: absolute; opacity: 1; z-index: 8675309; display: none; cursor: pointer;\">Save<\/span><\/p>\n<p><strong>Did you find this informative or useful? Please consider a small donation so I can expand and improve on what I deliver.<\/strong><\/p>\n<p><input title=\"PayPal - The safer, easier way to pay online!\" alt=\"Donate with PayPal button\" name=\"submit\" src=\"https:\/\/www.paypalobjects.com\/en_AU\/i\/btn\/btn_donateCC_LG.gif\" type=\"image\" \/><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.paypal.com\/en_AU\/i\/scr\/pixel.gif\" alt=\"\" width=\"1\" height=\"1\" border=\"0\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The USP is the United State&#8217;s Pharmacopeia. If you are selling pharmaceuticals in the USA, you need to follow the USP and are subject to FDA regulation.\u00a0 For the layperson, a pharmacopeia is an official publication containing a list of medicinal drugs with their effects and directions for their manufacturing, testing and use. The latest [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5,2],"tags":[42,43],"class_list":["post-357","post","type-post","status-publish","format-standard","hentry","category-documentation","category-the-regs","tag-regulations","tag-usp"],"_links":{"self":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/357","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/comments?post=357"}],"version-history":[{"count":4,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/357\/revisions"}],"predecessor-version":[{"id":1217,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/357\/revisions\/1217"}],"wp:attachment":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media?parent=357"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/categories?post=357"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/tags?post=357"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}