{"id":361,"date":"2016-02-16T13:34:11","date_gmt":"2016-02-16T03:34:11","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=361"},"modified":"2020-07-29T14:43:51","modified_gmt":"2020-07-29T03:43:51","slug":"fda-guide-to-inspections","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2016\/02\/16\/fda-guide-to-inspections\/","title":{"rendered":"FDA Guide To Inspections"},"content":{"rendered":"<p>A great reference for ensuring you are audit ready are the FDA&#8217;s Guide to Inspections documents and Guidance for Industry documents.<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/ICECI\/Inspections\/InspectionGuides\/default.htm\" target=\"_blank\" rel=\"noopener\">The FDA Inspection guides are freely available from here<\/a>.<\/p>\n<p>For my own reference and review, I&#8217;ve saved some of the Guidance for Industry documents below.\u00a0 However, you <a href=\"http:\/\/www.fda.gov\/AnimalVeterinary\/GuidanceComplianceEnforcement\/GuidanceforIndustry\/\" target=\"_blank\" rel=\"noopener\">can get them all from this link<\/a>.<\/p>\n<ul>\n<li><a href=\"http:\/\/paulyeatman.net.au\/wp-content\/uploads\/2016\/08\/guidance-for-industry-investigating-OOS-test-results-for-pharmaceutical-production.pdf\">guidance for industry &#8211; investigating OOS test results for pharmaceutical production<\/a><\/li>\n<li><a href=\"http:\/\/paulyeatman.net.au\/wp-content\/uploads\/2016\/08\/Guidance-for-Industry-general-validation-principles.pdf\">Guidance for Industry &#8211; general validation principles<\/a><\/li>\n<li><a href=\"http:\/\/paulyeatman.net.au\/wp-content\/uploads\/2016\/08\/guidance-for-industry-q7a-GMP-for-API.pdf\">guidance for industry &#8211; q7a GMP for API<\/a>I<\/li>\n<li><a href=\"http:\/\/paulyeatman.net.au\/wp-content\/uploads\/2016\/08\/FDA-270-Guidance-for-Industry-Sterile-Drug-Products-Produced-by-Aseptic-Processing-.pdf\">FDA-270-Guidance for Industry Sterile Drug Products Produced by Aseptic Processing<\/a><\/li>\n<li><a href=\"http:\/\/paulyeatman.net.au\/wp-content\/uploads\/2016\/08\/FDA-Guide-to-Inspections-of-HPW-4-27-07.pdf\">FDA Guide to Inspections of HPW 4-27-07<\/a><\/li>\n<li><a href=\"http:\/\/paulyeatman.net.au\/wp-content\/uploads\/2016\/08\/FDA-guidance-for-industry-sterile-drug-products-produced-by-aseptic-processing.pdf\">FDA guidance for industry &#8211; sterile drug products produced by aseptic processing<\/a><\/li>\n<\/ul>\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>A great reference for ensuring you are audit ready are the FDA&#8217;s Guide to Inspections documents and Guidance for Industry documents. The FDA Inspection guides are freely available from here. For my own reference and review, I&#8217;ve saved some of the Guidance for Industry documents below.\u00a0 However, you can get them all from this link. [&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":[46,29,37,12],"class_list":["post-361","post","type-post","status-publish","format-standard","hentry","category-documentation","category-the-regs","tag-auditing","tag-documentation","tag-fda","tag-guidelines"],"_links":{"self":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/361","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=361"}],"version-history":[{"count":5,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/361\/revisions"}],"predecessor-version":[{"id":1228,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/361\/revisions\/1228"}],"wp:attachment":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media?parent=361"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/categories?post=361"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/tags?post=361"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}