{"id":172,"date":"2016-02-03T10:35:22","date_gmt":"2016-02-03T00:35:22","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=172"},"modified":"2018-11-28T12:05:33","modified_gmt":"2018-11-28T02:05:33","slug":"approaches-to-trend-analysis-of-micro-monitoring-during-aseptic-processing","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2016\/02\/03\/approaches-to-trend-analysis-of-micro-monitoring-during-aseptic-processing\/","title":{"rendered":"Approaches to trend analysis of micro monitoring during aseptic processing?"},"content":{"rendered":"<p><strong>The Question posed on <a href=\"http:\/\/www.linkedin.com\/groups\/3714467\/3714467-6099322523185352706\" target=\"_blank\" rel=\"noopener\">LinkedIn<\/a>.<\/strong><\/p>\n<p>&#8220;Companies are expected to perform trending of their monitoring data. Detecting adverse trends should help to prevent exceedings of regulatory limits, as defined e.g. in Annex 1 to the EU or PIC\/S GMP Guide for aseptic operations.<\/p>\n<p>As you all know, microbial counts do not follow a normal Gaussian but a logarithmic distribution, such that the classical way of calculating and defining thresholds for alert (often +\/- 2s) and action (+\/- 3s) cannot be applied.<\/p>\n<p>Hence, what alternative approaches to setting alert and action limits for microbio monitoring data (environment, staff, water, &#8230;) do you apply?&#8221;<\/p>\n<p><strong>My advice:<\/strong><\/p>\n<p>You need to have defined what your alert and action levels are and how many times in a row a site can be in alert before this constitutes an action. You also need to define how many below alert results may indicate an adverse trend.<\/p>\n<p>Basically you want to get what is heading out of control under control.<\/p>\n<p>You need to have a defined trending and reporting period and reports need to be signed off both by the microbiologist and QA manager.<\/p>\n<p>Your internal process and documents will be dependant on which regulatory bodies have oversight at your facility.<\/p>\n<p>The FDA, PDA, PIC(S), ICH and good resources like the PMF are valuable when developing your internal processes.<\/p>\n<p>Some resources:<br \/>\n<a href=\"http:\/\/www.fda.gov\/Food\/FoodScienceResearch\/LaboratoryMethods\/ucm124900.htm\" target=\"_blank\" rel=\"noopener\">http:\/\/www.fda.gov\/Food\/FoodScienceResearch\/LaboratoryMethods\/ucm124900.htm<\/a><\/p>\n<p><a href=\"http:\/\/www.microbiologyforum.org\/content\/file\/PMFNews.17.03.1103.pdf\" target=\"_blank\" rel=\"noopener\">http:\/\/www.microbiologyforum.org\/content\/file\/PMFNews.17.03.1103.pdf<\/a><\/p>\n<p><a href=\"https:\/\/www.pda.org\/docs\/default-source\/website-document-library\/chapters\/presentations\/midwest\/making-sense-of-your-environmental-monitoring-data.pdf?sfvrsn=4\" target=\"_blank\" rel=\"noopener\">https:\/\/www.pda.org\/docs\/default-source\/website-document-library\/chapters\/presentations\/midwest\/making-sense-of-your-environmental-monitoring-data.pdf?sfvrsn=4<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Question posed on LinkedIn. &#8220;Companies are expected to perform trending of their monitoring data. Detecting adverse trends should help to prevent exceedings of regulatory limits, as defined e.g. in Annex 1 to the EU or PIC\/S GMP Guide for aseptic operations. As you all know, microbial counts do not follow a normal Gaussian but [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21],"tags":[30,11,25],"class_list":["post-172","post","type-post","status-publish","format-standard","hentry","category-advice-provided","tag-data","tag-trending","tag-vem"],"_links":{"self":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/172","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=172"}],"version-history":[{"count":5,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/172\/revisions"}],"predecessor-version":[{"id":868,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/172\/revisions\/868"}],"wp:attachment":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media?parent=172"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/categories?post=172"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/tags?post=172"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}