{"id":112,"date":"2024-04-19T16:04:39","date_gmt":"2024-04-19T07:04:39","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?page_id=112"},"modified":"2025-10-15T16:14:16","modified_gmt":"2025-10-15T07:14:16","slug":"commissioning_qualification","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/commissioning_qualification\/","title":{"rendered":"Facility Construction\uff5cTrial operation\u3000-Commissioning &amp; Qualification-"},"content":{"rendered":"<div id=\"commissioning_qualification\">\n<div id=\"pagePath\">\n<ul>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/\">Home<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\">Services<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\">Engineering, Project Management<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/\">Facility Construction<\/a>\/<\/li>\n<li>Trial Operation -Commissioning &amp; Qualification-<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">Facility Construction<\/span><br class=\"wpTag\">Trial Operation<br class=\"wpTag\">-Commissioning &amp; Qualification-<br \/>\n<span class=\"h1Photo\"><br \/>\n<span class=\"maskBox\"><br \/>\n<span class=\"topCover\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\" alt=\"Facility Construction Trial Operation\u3000-Commissioning &amp; Qualification-\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg01 projectBtmImg\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service.webp\" alt=\"Facility Construction Trial Operation\u3000-Commissioning &amp; Qualification-\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg02 projectBtmImg\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service.webp\" alt=\"Facility Construction Trial Operation\u3000-Commissioning &amp; Qualification-\"><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/h1>\n<\/div>\n<\/div>\n<div class=\"content\">\n<div class=\"mainBox\">\n<article id=\"conts\">\n<div class=\"comFlowListBox topFlowBox\">\n<ul class=\"comFlowList\">\n<li class=\"li01\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/business_concept\/\"><span class=\"txtSpan\">Business Concept<\/span><\/a><\/li>\n<li class=\"li02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/conceptual_design\/\"><span class=\"txtSpan\">Conceptual Design<\/span><\/a><\/li>\n<li class=\"li03\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/basic_design\/\"><span class=\"txtSpan\">Basic Design<\/span><\/a><\/li>\n<li class=\"li04\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/purocurement\/\"><span class=\"txtSpan\">Procurement<\/span><\/a><\/li>\n<li class=\"li05\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\"><span class=\"txtSpan\">Detailed Design \/ Production Management<\/span><\/a><\/li>\n<li class=\"li06\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\"><span class=\"txtSpan\">Construction<\/span><\/a><\/li>\n<li class=\"on active\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/commissioning_qualification\/\"><span class=\"txtSpan\">Trial Operation<\/span><\/a><\/li>\n<li class=\"liStyle\"><a href=\"#\" class=\"no\"><span class=\"txtSpan\">Operation<\/span><\/a><\/li>\n<\/ul>\n<\/div>\n<section class=\"box\">\n<h2 class=\"headLine05\">Commissioning &amp; Qualification and Validation Process<\/h2>\n<p class=\"comTxt\">Commissioning &amp; Qualification represent the final stages in the trial operation phase. However, it is important to conduct checks at each stage from the initial design phase to maintain quality and ensure the project proceeds smoothly.<\/p>\n<div class=\"biPhoto\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/project\/commissioning_qualification\/photo01.webp\" alt=\"Commissioning &amp; Qualification and Validation Process\"><span class=\"photoIco\"><a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/project\/commissioning_qualification\/photo01.webp\" class=\"popImg\">&nbsp;<\/a><\/span><\/div>\n<div class=\"comLink\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/\"><span class=\"subSpan\">See the Flow of Facility Construction<\/span><\/a><\/div>\n<\/section>\n<section>\n<h2 class=\"headLine05\"><small>In a pharmaceutical factory\u2026<\/small>Validation (Commissioning &amp; Qualification)<\/h2>\n<p class=\"comTxt text\">According to the GMP ordinance, \u201cValidation\u201d is defined as \u201cthe action of verifying that the structure, equipment, and procedures of a manufacturing site, as well as the methods of manufacturing and quality control procedures, produce the expected results, and documenting this verification.\u201d<\/p>\n<p class=\"comTxt\">Achieving high-quality and efficient validation in new construction or renovation projects of pharmaceutical factories is one of the most important tasks to accomplish.<\/p>\n<div class=\"comBorBox\">\n<section class=\"validation\">\n<h3 class=\"headLine06\">Validation Support by CM Plus<\/h3>\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/project\/commissioning_qualification\/photo02.webp\" alt=\"Validation Support by CM Plus\"><\/div>\n<div class=\"textBox\">\n<p class=\"wpTag\">CM Plus possesses \u201cValidation Management Technology,\u201d which enables efficient validation through a consistent philosophy from the initial stages of the project.<\/p>\n<\/div>\n<\/div>\n<div class=\"comLink\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/qualification_validation\/\"><span class=\"subSpan\">Flow of Validation Consulting<\/span><\/a><\/div>\n<\/section>\n<\/div>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">See other phases<\/h2>\n<div class=\"comFlowListBox\">\n<ul class=\"comFlowList\">\n<li class=\"li01 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/business_concept\/\"><span class=\"txtSpan\">Business Concept<\/span><\/a><\/li>\n<li class=\"li02 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/conceptual_design\/\"><span class=\"txtSpan\">Conceptual Design<\/span><\/a><\/li>\n<li class=\"li03 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/basic_design\/\"><span class=\"txtSpan\">Basic Design<\/span><\/a><\/li>\n<li class=\"li04 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/purocurement\/\"><span class=\"txtSpan\">Procurement<\/span><\/a><\/li>\n<li class=\"li05 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\"><span class=\"txtSpan\">Detailed Design \/ Production Management<\/span><\/a><\/li>\n<li class=\"li06 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\"><span class=\"txtSpan\">Construction<\/span><\/a><\/li>\n<li class=\"on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/commissioning_qualification\/\"><span class=\"txtSpan\">Trial Operation<\/span><\/a><\/li>\n<li class=\"liStyle on\"><a href=\"#\" class=\"no\"><span class=\"txtSpan\">Operation<\/span><\/a><\/li>\n<\/ul>\n<\/div>\n<ul class=\"comLinkListBox\">\n<li>\n<div class=\"comLink smallComLink\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/\"><span class=\"subSpan\">Read more about overview of flow of facility construction<\/span><\/a><\/div>\n<\/li>\n<\/ul>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Related Contents<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/project_details\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/span><br \/>\n<span class=\"subSpan\">Projects<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/about_cm_plus\/record\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/span><br \/>\n<span class=\"subSpan\">Performance by Numbers<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section class=\"validation\">\n<h2 class=\"headLine04\">Useful Information<\/h2>\n<p class=\"wpTag\">Please also refer to the articles on our information dissemination site, \u201cGMP Platform.\u201d Although the title contains \u201cPharmaceutical Factory Construction,\u201d the content is applicable to the construction of factories in various industries, not limited to pharmaceutical factories.<\/p>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo07.webp\" alt=\"\u201cHow to Build a Pharmaceutical Plant\u201d\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cHow to Build a Pharmaceutical Plant\u201d<\/h4>\n<p class=\"wpTag\">This article discusses how to minimize the burden of validation, which requires substantial time and cost in pharmaceutical factory construction projects, while achieving both GMP compliance and cost rationality in the deployment of qualification. We propose the concept of Lean Qualification. More details can be found in the article \u201cKnow-how for Pharmaceutical Factory Construction\u201d on our information dissemination site, \u201cGMP Platform.\u201d<\/p>\n<\/div>\n<\/div>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=7529\" target=\"_blank\" rel=\"noopener noreferrer\">\u201cHow to Build a Pharmaceutical Plant\u201d<br class=\"wpTag\">Implementing a Project with the Lean Qualification Approach [1st Installment]<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Japanese only)<\/span><\/div>\n<\/div>\n<\/section>\n<section class=\"comOtherBox comOtherBox02\">\n<h2 class=\"headLine04\">Other Services<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo02.webp\" alt=\"Consulting\"><\/span><br \/>\n<span class=\"subSpan\">Consulting<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/support_for_training\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo03.webp\" alt=\"Education\/Training Support\"><\/span><br \/>\n<span class=\"subSpan\">Education\/Training Support<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo04.webp\" alt=\"Technical Information Services\"><\/span><br \/>\n<span class=\"subSpan\">Technical Information Services<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<\/article>\n<aside id=\"sideBar\">\r\n\t<p class=\"sideTtl\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\"><span class=\"txtSpan barlow\">Services<\/span><\/a><\/p>\r\n\t<ul id=\"menu-service\" class=\"sideList\"><li id=\"menu-item-238\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-238\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\">Engineering, Project Management<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-253\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-253\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/production_facility\/\">One-Stop Service for Production Facilities<\/a><\/li>\n\t<li id=\"menu-item-240\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-240\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/construction_management\/\">About Construction Management<\/a><\/li>\n\t<li id=\"menu-item-239\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-239\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/feature\/\">Construction Management by CM Plus<\/a><\/li>\n\t<li id=\"menu-item-6143\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-6143\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_management_consultant\/\">Project Management Consultant (PMC)<\/a><\/li>\n\t<li id=\"menu-item-243\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-243\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/\">Facility Construction<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-245\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-245\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/business_concept\/\">Business Concept<\/a><\/li>\n\t\t<li id=\"menu-item-246\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-246\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/conceptual_design\/\">Conceptual Design<\/a><\/li>\n\t\t<li id=\"menu-item-247\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-247\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/basic_design\/\">Basic Design<\/a><\/li>\n\t\t<li id=\"menu-item-248\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-248\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/purocurement\/\">Procurement<\/a><\/li>\n\t\t<li id=\"menu-item-249\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-249\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\">Detailed Design \/ Production Management<\/a><\/li>\n\t\t<li id=\"menu-item-244\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-244\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/commissioning_qualification\/\">Trial Operation -Commissioning &#038; 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Qualification- Facility ConstructionTrial Operation-Commissioning &amp; Qualification- Business Concept Conceptual Design Basic Design Procurement Detailed Design \/ Production Management Construction Trial Operation Operation Commissioning &amp; Qualification and Validation Process Commissioning &amp; Qualification represent the final stages in the trial operation phase. However, it is important to conduct checks at each stage from the initial design phase to maintain quality and ensure the project proceeds smoothly. &nbsp; See the Flow of Facility Construction In a pharmaceutical factory\u2026Validation (Commissioning &amp; Qualification) According to the GMP ordinance, \u201cValidation\u201d is defined as \u201cthe action of verifying that the structure, equipment, and procedures of a [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":100,"menu_order":32,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[7,12,13,10],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Trial Operation -Commissioning &amp; Qualification-\uff5cFacility Construction\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"The process and key points for success in Trial operation and Commissioning &amp; Qualification. 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