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="LRdI3tWao4"><a href="https://cm-plus.co.jp/en/news/other/2026_0901/">New Column Series – “PMDA Orange Letter” – Now Up to Part 2</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://cm-plus.co.jp/en/news/other/2026_0901/embed/#?secret=LRdI3tWao4" width="600" height="338" title="“New Column Series – “PMDA Orange Letter” – Now Up to Part 2” — CM Plus" data-secret="LRdI3tWao4" 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/2026/06/GMPP_cat_Others_14_e548213f52.jpg928485Series Overview To encourage voluntary quality improvements and proactive compliance at pharmaceutical manufacturing sites, Japan’s regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), regularly publishes anonymized and highly practical findings from its GMP inspections. Released under the format known as the “Orange Letter” since 2022, these documents serve as vital references for life science professionals. Rather than just listing regulatory violations, the series focuses on the root causes of compliance issues and shares real-world case studies based on the Japanese GMP Ministerial Order. The articles cover all the critical quality elements, such as material lifecycle management, sterile manufacturing controls, facility maintenance, and contamination control strategies (CCS). By reviewing these […]