1.0CM Plushttps://cm-plus.co.jp/encmp_otanihttps://cm-plus.co.jp/en/author/cmp_otani/rich600338<blockquote class="wp-embedded-content" data-secret="X30kDtmox3"><a href="https://cm-plus.co.jp/en/column/gmp/2026_0803-2/">PMDA ORANGE LETTER_2026.06</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://cm-plus.co.jp/en/column/gmp/2026_0803-2/embed/#?secret=X30kDtmox3" width="600" height="338" title="“PMDA ORANGE LETTER_2026.06” — CM Plus" data-secret="X30kDtmox3" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript"> /* <![CDATA[ */ /*! This file is auto-generated */ !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); /* ]]> */ </script> https://cm-plus.co.jp/en/wp-content/uploads/2026/08/GMPP_cat_EN_other2.jpg928485ORANGE 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 “ORANGE Letter” since 2022. CM Plus provides abridged English translations of the Orange Letters, for our clients’ reference. Author: Observed Regulatory Attention/Notification of GMP Elements LETTER Issue: June 2026 Title: Management of Expiration Date and Retest Period of API – Preventing Misunderstandings Regarding Retest Related GMP Ministerial Ordinance Clause: Article 3-2, etc. Cases Due to insufficient understanding of the definitions of the expiration date and the retest period APIs, established […]