{"id":2416,"date":"2018-12-15T21:48:44","date_gmt":"2018-12-15T12:48:44","guid":{"rendered":"http:\/\/spera.rdy.jp\/?page_id=2416"},"modified":"2019-02-06T00:51:36","modified_gmt":"2019-02-05T15:51:36","slug":"qbd","status":"publish","type":"page","link":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/technology\/drug\/qbd\/","title":{"rendered":"Establishment of robust manufacturing process using QbD approach"},"content":{"rendered":"<p>API process control based on ICH\u2019s Q11 requires the process understanding in deep, by QbD approach as follows;<\/p>\n<p>(1) selection of API\u2019s critical quality attributes (CQAs) and risk assessment (FMEA), (2) extraction of PCPPs (Potential Critical Process Parameters) and evaluation by multi-dimensional experiment such as quality engineering and design of experiment (DoE) (3) identification of CPPs (Critical Process Parameters). The process optimization through the QbD approach provides a robust manufacturing process with focusing on the commercial application including responses to the inquiries from health authorities.<\/p>\n<p><a href=\"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-content\/uploads\/2019\/02\/05en.jpg\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-content\/uploads\/2019\/02\/05en.jpg\" alt=\"Plots of predicted and measured values \/ Contour line profile\" width=\"562\" height=\"339\" class=\"alignnone size-full wp-image-4409\" srcset=\"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-content\/uploads\/2019\/02\/05en.jpg 562w, https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-content\/uploads\/2019\/02\/05en-300x181.jpg 300w, https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-content\/uploads\/2019\/02\/05en-240x145.jpg 240w\" sizes=\"(max-width: 562px) 100vw, 562px\" \/><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>API process control based on ICH\u2019s Q11 requires the process understanding in deep, by QbD approach as follows; [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2327,"menu_order":6,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_locale":"en_US","_original_post":"688","footnotes":""},"class_list":["post-2416","page","type-page","status-publish","hentry","en-US"],"acf":[],"_links":{"self":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2416","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/comments?post=2416"}],"version-history":[{"count":0,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2416\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/pages\/2327"}],"wp:attachment":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/media?parent=2416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}