{"version":"1.0","provider_name":"CM Plus","provider_url":"https:\/\/cm-plus.co.jp\/en","author_name":"cmp_araki","author_url":"https:\/\/cm-plus.co.jp\/en\/author\/cmp_araki\/","title":"PMDA ORANGE LETTER_2026.07\uff5cCM Plus","type":"rich","width":600,"height":338,"html":"<blockquote class=\"wp-embedded-content\" data-secret=\"wIGDOszTx6\"><a href=\"https:\/\/cm-plus.co.jp\/en\/column\/gmp\/2026_0814\/\">PMDA ORANGE LETTER_2026.07<\/a><\/blockquote><iframe sandbox=\"allow-scripts\" security=\"restricted\" src=\"https:\/\/cm-plus.co.jp\/en\/column\/gmp\/2026_0814\/embed\/#?secret=wIGDOszTx6\" width=\"600\" height=\"338\" title=\"&#8220;PMDA ORANGE LETTER_2026.07&#8221; &#8212; CM Plus\" data-secret=\"wIGDOszTx6\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\" class=\"wp-embedded-content\"><\/iframe><script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\n\/*! This file is auto-generated *\/\r\n!function(d,l){\"use strict\";l.querySelector&&d.addEventListener&&\"undefined\"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!\/[^a-zA-Z0-9]\/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret=\"'+t.secret+'\"]'),o=l.querySelectorAll('blockquote[data-secret=\"'+t.secret+'\"]'),c=new RegExp(\"^https?:$\",\"i\"),i=0;i<o.length;i++)o[i].style.display=\"none\";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute(\"style\"),\"height\"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):\"link\"===t.message&&(r=new URL(s.getAttribute(\"src\")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener(\"message\",d.wp.receiveEmbedMessage,!1),l.addEventListener(\"DOMContentLoaded\",function(){for(var e,t,s=l.querySelectorAll(\"iframe.wp-embedded-content\"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute(\"data-secret\"))||(t=Math.random().toString(36).substring(2,12),e.src+=\"#?secret=\"+t,e.setAttribute(\"data-secret\",t)),e.contentWindow.postMessage({message:\"ready\",secret:t},\"*\")},!1)))}(window,document);\n\/* ]]> *\/\n<\/script>\n","thumbnail_url":"https:\/\/cm-plus.co.jp\/en\/wp-content\/uploads\/2026\/08\/GMPP_cat_EN_other2.jpg","thumbnail_width":928,"thumbnail_height":485,"description":"ORANGE LETTER To encourage voluntary quality improvements at pharmaceutical manufacturing sites, Japanese regulatory agency PMDA has been publishing anonymized, highly useful findings from its inspections based on Japanese GMP Ministerial Order. These are published in a format known as the &#8220;ORANGE Letter&#8221; since 2022. CM Plus provides abridged English translations of the Orange Letters, for our clients&#8217; reference. Observed Regulatory Attention\/Notification of GMP Elements LETTER Author: PMDA Issue: July 2026 Title: Airflow Visualization Testing (Smoke Testing) in Aseptic Areas Related GMP Ministerial Ordinance Clause: Article 24-3 Cases Defects in product contamination prevention control were observed. In a smoke test conducted in an aseptic area, the site failed to detect the [&hellip;]"}