1.0CM Plushttps://cm-plus.co.jp/encmp_arakihttps://cm-plus.co.jp/en/author/cmp_araki/rich600338<blockquote class="wp-embedded-content" data-secret="rXPhDLjX6z"><a href="https://cm-plus.co.jp/en/column/gmp/2026_1023/">GMP WATCH NEWS – A Veteran’s Perspective［3］</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://cm-plus.co.jp/en/column/gmp/2026_1023/embed/#?secret=rXPhDLjX6z" width="600" height="338" title="“GMP WATCH NEWS – A Veteran’s Perspective［3］” — CM Plus" data-secret="rXPhDLjX6z" 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_Others_127.jpg928458Paradigm Shifts in Pharmaceutical Quality Systems A Historical Review and Future Perspectives [Part 3] From QC to the Pharmaceutical Quality System (PQS) When GMP was first introduced in 1963, the “testing” conducted by the QC department played a central role. However, as GMP evolved, there was a dramatic increase in complex tasks beyond testing, such as document control, change control, and deviation management. Consequently, the FDA revised CGMP in 1978, significantly strengthening the authority of the QC department. It clarified the department’s independence from the manufacturing department and its final authority over release decisions, effectively mandating that the QC department also assume the current role of Quality Assurance (QA). Furthermore, […]