{"id":677,"date":"2017-01-08T16:21:54","date_gmt":"2017-01-08T06:21:54","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=677"},"modified":"2020-07-29T14:32:10","modified_gmt":"2020-07-29T03:32:10","slug":"pics-guide-for-good-manufacturing-practice-for-medicinal-products-2013","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2017\/01\/08\/pics-guide-for-good-manufacturing-practice-for-medicinal-products-2013\/","title":{"rendered":"PIC\/S Guide for Good Manufacturing Practice for Medicinal Products (2013)"},"content":{"rendered":"<p>From Jan 1, 2017, the PIC\/S GMP guide for Medicinal Products V13 will be in effect.\u00a0 In Australia, the TGA requires version 9 is used, though rumour has it, version 13&#8217;s going to be adopted soon.\u00a0 If such <a href=\"http:\/\/www.cmaustralia.org.au\/Resources\/Documents\/Submissions\/CHC-%20Response%20to%20proposal%20for%20automatic%20adoption%20of%20PICS%20August%202013%20Final.pdf\">proposals as this one<\/a>, which is mainly concerned with herbal &#8220;medicine&#8221; from the Complimentary Healthcare Council are ratified, then all future PIC\/s updates will automatically apply to Australian manufacture.\u00a0 Something to keep an eye on.<\/p>\n<p>Compliance wise adopting PICS\/s 13 over 9 is\u00a0 not too big as deal as the PIC\/S guide is based on old <a href=\"http:\/\/paulyeatman.net.au\/wp-content\/uploads\/2003\/01\/Q7A-Guidance-API-2001-5-22-07.pdf\">ICH Q7A guidelines<\/a> dating from August 2001 and the right and wrongs do not change much over time unless something major takes place.\u00a0 What manufacturers will need to pay attention to are the changes between version 9 and 13, namely:<\/p>\n<ul>\n<li>Chapter 1, 2, 4, 6 and 7 revised &#8211; Part 1<\/li>\n<li>Annex 2, 6, 7, 11, 13, 14 and 15 revised<\/li>\n<li>QRM principles in PIC\/S GMP added &#8211; Part 2<\/li>\n<\/ul>\n<div id=\"attachment_678\" style=\"width: 310px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-678\" class=\"size-medium wp-image-678\" src=\"http:\/\/paulyeatman.net.au\/wp-content\/uploads\/2017\/01\/pe009-13-300x228.png\" alt=\"Screen shot of PIC's news item\" width=\"300\" height=\"228\" srcset=\"https:\/\/paulyeatman.net.au\/wp-content\/uploads\/2017\/01\/pe009-13-300x228.png 300w, https:\/\/paulyeatman.net.au\/wp-content\/uploads\/2017\/01\/pe009-13-768x582.png 768w, https:\/\/paulyeatman.net.au\/wp-content\/uploads\/2017\/01\/pe009-13-1x1.png 1w, https:\/\/paulyeatman.net.au\/wp-content\/uploads\/2017\/01\/pe009-13.png 898w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><p id=\"caption-attachment-678\" class=\"wp-caption-text\">Screen shot of PIC&#8217;s news item<\/p><\/div>\n<p><a href=\"https:\/\/www.picscheme.org\/layout\/document.php?id=986\">Link to guide<\/a>. (possibly dead) &#8211; Google search will find it for you.<\/p>\n<p>Based on the contents of V9, things to review:<\/p>\n<ul>\n<li>Quality Management<\/li>\n<li>Personnel<\/li>\n<li>Documentation<\/li>\n<li>Quality Control<\/li>\n<li>Contract Manufacturing and analysis<\/li>\n<\/ul>\n<p>You should already be in control of the above areas as otherwise, you&#8217;d be having and uncomfortable 3rd party audit experience.\u00a0 The overall principles do not change, just the fine-print.<\/p>\n<p>Annex 1 deals with the manufacture of sterile medicinal products, so not much impact to us there. If you are performing risk assessments and utilising ISO9001, QRM should already be familiar to you.<\/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\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>From Jan 1, 2017, the PIC\/S GMP guide for Medicinal Products V13 will be in effect.\u00a0 In Australia, the TGA requires version 9 is used, though rumour has it, version 13&#8217;s going to be adopted soon.\u00a0 If such proposals as this one, which is mainly concerned with herbal &#8220;medicine&#8221; from the Complimentary Healthcare Council are [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7,2],"tags":[44],"class_list":["post-677","post","type-post","status-publish","format-standard","hentry","category-commentary","category-the-regs","tag-pics"],"_links":{"self":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/677","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=677"}],"version-history":[{"count":5,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/677\/revisions"}],"predecessor-version":[{"id":1196,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/677\/revisions\/1196"}],"wp:attachment":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media?parent=677"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/categories?post=677"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/tags?post=677"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}