{"id":1094,"date":"2020-03-20T10:59:03","date_gmt":"2020-03-19T23:59:03","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=1094"},"modified":"2020-05-06T14:36:35","modified_gmt":"2020-05-06T03:36:35","slug":"question-about-accelerated-stability-study","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2020\/03\/20\/question-about-accelerated-stability-study\/","title":{"rendered":"Question Regarding PIC\/S PE009-14"},"content":{"rendered":"

The current GMPs in Australia adhere to the PIC\/S Guide to Good Manufacturing Practice, (PE009-13). This guide was adopted by the TGA in 2018 and the TGA has “just given” notice that it intends to adopt the current version of the PIC\/S Guide (PE009-14) by July 1st 2020.<\/span><\/h4>\n

The Question posed on <\/a><\/strong>LinkedIn:<\/strong><\/h4>\n

“…I have read PIC\/S guidelines, when I was working in Pharmaceutical company. Currently, I am not working in Pharmaceutical company. I would like to keep my knowledge updated about what’s new in regulatory guidelines in Pharmaceutical. Would you please let me know, where can I get copy of new PIC\/S??<\/span>…<\/span>“<\/h4>\n

<\/p>\n

My reply was this:<\/h4>\n

“H<\/span>i NIta. <\/span><\/p>\n

PIC\/S makes their doccos available to anyone. Here’s the link for you: <\/span>https:\/\/www.picscheme.org\/en\/publications?tri=gmp<\/a> <\/span><\/p>\n

\n
\n
\n

Kind Regards<\/span><\/p>\n

Paul”<\/span><\/p>\n<\/div>\n

I am happy I saw the notification as now I am off to read PE009-13 and compare it to PE009-14.<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The current GMPs in Australia adhere to the PIC\/S Guide to Good Manufacturing Practice, (PE009-13). This guide was adopted by the TGA in 2018 and the TGA has “just given” notice that it intends to adopt the current version of the PIC\/S Guide (PE009-14) by July 1st 2020. The Question posed on LinkedIn: “…I have […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21,5],"tags":[12,44,41],"class_list":["post-1094","post","type-post","status-publish","format-standard","hentry","category-advice-provided","category-documentation","tag-guidelines","tag-pics","tag-tga"],"_links":{"self":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1094","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=1094"}],"version-history":[{"count":6,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1094\/revisions"}],"predecessor-version":[{"id":1118,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1094\/revisions\/1118"}],"wp:attachment":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media?parent=1094"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/categories?post=1094"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/tags?post=1094"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}