{"id":157,"date":"2024-04-19T16:38:54","date_gmt":"2024-04-19T07:38:54","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?page_id=157"},"modified":"2024-08-15T14:58:31","modified_gmt":"2024-08-15T05:58:31","slug":"gmdp_consulting","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/gmdp_consulting\/","title":{"rendered":"Pharmaceutical GMP &#038; GDP Consulting"},"content":{"rendered":"<div id=\"gmdp_consulting\">\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\/consulting\/\">Consulting<\/a>\/<\/li>\n<li>Pharmaceutical GMP &amp; GDP Consulting<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">Consulting<\/span><br class=\"wpTag\">Pharmaceutical GMP &amp; GDP Consulting<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=\"Consulting Pharmaceutical GMP &amp; GDP Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg01\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service08.webp\" alt=\"Consulting Pharmaceutical GMP &amp; GDP Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg02\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service08.webp\" alt=\"Consulting Pharmaceutical GMP &amp; GDP Consulting\"><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<section class=\"sec01 secBox\">\n<h2 class=\"headLine05\">Do you have any of these wishes regarding building in quality?<\/h2>\n<div class=\"comWishBox\">\n<div class=\"area\">\n<ul class=\"comCheckList\">\n<li>We want to prepare for regulatory inspections.<\/li>\n<li>We want a partner who can concretely advance the construction\/improvement of quality systems.<\/li>\n<li>We want to eliminate concerns about problems and risks lurking in the manufacturing facility.<\/li>\n<li>We want personnel responsible for auditing external contractors\u2019 manufacturing plants and raw material suppliers.<\/li>\n<li>We want to efficiently establish a quality system in new business areas.<\/li>\n<\/ul>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/arrow04.webp\" alt=\"\"><\/div>\n<div class=\"area pink\">\n<h3 class=\"headLine06\">With CM Plus\u2019s GMDP Consulting, we offer the following support for <\/h3>\n<ul class=\"comCheckList red\">\n<li>Regulatory inspections such as those by the FDA and PMDA:\n<ul class=\"comRaiList\">\n<li>Mock inspections<\/li>\n<li>Inspection response training<\/li>\n<li>Back office support during inspections<\/li>\n<li>Assistance in responding to inspection observations findings<\/li>\n<li>Support for improving identified issues<\/li>\n<li>Interpretation for overseas audits<\/li>\n<\/ul>\n<\/li>\n<li>Comprehensive proposals for the establishment construction and improvement of PQS, storage management of raw materials, facility workflow improvements, and on-site operational improvements. Our strength includes the smooth proposal of facility improvements, supported by our in-house engineering consultants.<\/li>\n<li>By conducting GAP analysis, we first clarify the discrepancies (gaps) between the \u201ccurrent state\u201d and the \u201cdesired future state\u201d of the manufacturing site. We identify hidden risks and issues from both equipment\/facility and quality system perspectives and provide improvement proposals.<\/li>\n<li>Experienced consultants conduct quality audits on your behalf.<\/li>\n<li>We train GMP Auditors (inspectors).<\/li>\n<li>Based on extensive experience, we support the establishment of quality systems and preparation of procedures tailored to the scale of personnel and other conditions.<br \/>\n\t<br class=\"wpTag\">Additionally, CM Plus houses regulatory and validation experts, allowing us to offer one-stop consultations for these matters as well.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/section>\n<div class=\"sec02 secBox\">\n<!-- \n\n<h2 class=\"headLine05\">\u5b9f\u7e3e<\/h2>\n\n --><br \/>\n<!-- \n\n<h3 class=\"headLine06\">\u904e\u53bb5\u5e74\u9593\u306e\u5b9f\u7e3e<br class=\"sp\">\uff082018\uff5e2023\u5e74\uff09<\/h3>\n\n\n\n\n<table class=\"tableD\">\n\n\n<thead>\n\n\n<tr>\n\n\n<th>\u5e74<\/th>\n\n\n\n\n<th>\u304a\u5ba2\u69d8\u306e<br class=\"sp\">\u6982\u8981<\/th>\n\n\n\n\n<th>\u696d\u52d9\u6982\u8981<\/th>\n\n\n\n\n<th>\u652f\u63f4\u671f\u9593<\/th>\n\n\n<\/tr>\n\n\n<\/thead>\n\n\n\n\n<tbody>\n\n\n<tr>\n\n\n<td>2023<\/td>\n\n\n\n\n<td>\u56fd\u5185\u533b\u85ac\u54c1\u88fd\u9020\u4f1a\u793e<\/td>\n\n\n\n\n<td>\u56fd\u5185\u5f53\u5c40\u67fb\u5bdf\u6307\u6458\u4e8b\u9805\u6539\u5584\u652f\u63f4<\/td>\n\n\n\n\n<td>\u25ef\u5e74<\/td>\n\n\n<\/tr>\n\n\n\n\n<tr>\n\n\n<td>2023<\/td>\n\n\n\n\n<td>\u6d77\u5916\u533b\u85ac\u54c1\u88fd\u9020\u4f1a\u793e<\/td>\n\n\n\n\n<td>PMDA\u67fb\u5bdf\u6e96\u5099\u652f\u63f4<\/td>\n\n\n\n\n<td>\u25ef\u5e74<\/td>\n\n\n<\/tr>\n\n\n\n\n<tr>\n\n\n<td>2022<\/td>\n\n\n\n\n<td>\u6d77\u5916\u539f\u85ac\u88fd\u9020\u4f1a\u793e<\/td>\n\n\n\n\n<td>\u56fd\u5185\u533b\u85ac\u54c1\u4f1a\u793e\u306e\u305f\u3081\u306e\u4ee3\u884c\u76e3\u67fb<\/td>\n\n\n\n\n<td>\u25ef\u30f5\u6708<\/td>\n\n\n<\/tr>\n\n\n\n\n<tr>\n\n\n<td>2021<\/td>\n\n\n\n\n<td>\u56fd\u5185\u533b\u85ac\u54c1\u88fd\u9020\u8ca9\u58f2\u4f1a\u793e<\/td>\n\n\n\n\n<td>\u81ea\u5df1\u70b9\u691c\u652f\u63f4<\/td>\n\n\n\n\n<td>\u25ef\u30f5\u6708<\/td>\n\n\n<\/tr>\n\n\n<\/tbody>\n\n\n<\/table>\n\n --><\/p>\n<p class=\"title\">First-rate consultants in\/outside Japan will support you fo quality improvement by providing GMDP improvement consulting services.<\/p>\n<div class=\"biPhoto smallPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/gmdp_consulting\/photo01.webp\" alt=\"First-rate consultants in\/outside Japan will support you fo quality improvement by providing GMDP improvement consulting services.\"><br \/>\n<span class=\"photoIco\"><br \/>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/gmdp_consulting\/photo01.webp\" class=\"popImg\">&nbsp;<\/a><br \/>\n<\/span>\n<\/div>\n<\/div>\n<section class=\"sec03 secBox\">\n<h2 class=\"headLine05\">Support for improving<\/h2>\n<h3 class=\"headLine06\">A\uff1aSupport for establishing\/improving your quality system<\/h3>\n<p class=\"comTxt\">As to manufacturing control\/quality control, which supports quality of drugs and related to all the activities from B to E shown below, CM Plus provides support for establishment and continuous improvement according to guidelines such as &#8220;PIC\/S GMP Guide Part I\/II&#8221;. We makes proposals how it should be about SOP&#8217;s document system established based on your quality policies, and provide support for establishing written procedures and records which support quality at the manufacturing site.<\/p>\n<h3 class=\"headLine06\">B\uff1aProposals for improvement of facility and equipment systems<\/h3>\n<p class=\"comTxt\">CM Plus reviews the layout, cleanliness classification, the flow of personnel and materials according to GMP then makes proposals of measures for improvement.<\/p>\n<h3 class=\"headLine06\">C\uff1aSupport for establishing\/improving your raw material system<\/h3>\n<p class=\"comTxt\">CM Plus makes proposals on how to improve the selection and management of suppliers, the management of warehouse storing raw materials and products, management of carrying materials in\/out of warehouses, and distribution.<\/p>\n<h3 class=\"headLine06\">D\uff1aSupport for establishing\/improving lab control system<\/h3>\n<p class=\"comTxt\">CM Plus provides support for establishing systems to control the whole lab including control of samples, reference standards and reagents, qualification, maintenance, and calibration of laboratory instruments, and analytical method validation and ensuring data integrity.<\/p>\n<h3 class=\"headLine06\">E\uff1aSupport for validation activities<\/h3>\n<p class=\"comTxt\">After the publication of &#8220;FDA Guidance&#8221; in 2011 and the revision of &#8220;PIC\/S GMP Guide Annex 15&#8221; in 2015, the concept of process validation drastically changed and was positioned as continuous activities to be done throughout product lifecycle. CM Plus reviews our clients&#8217; CMC data and propose effective approaches so that you can ensure appropriate traceability of your evidence data accumulated during development of your products. Also, we will support our clients for developing continuous improvement based on product quality reviews.<\/p>\n<ul class=\"comInfoList\">\n<li>\n<p class=\"wpTag\">For the validation of manufacturing facilities and architectural equipment, please see here.<\/p>\n<div class=\"comLink\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/qualification_validation\/\"><span class=\"subSpan\">Validation Consulting<\/span><\/a><\/div>\n<\/li>\n<\/ul>\n<\/section>\n<section class=\"sec04 secBox\">\n<h2 class=\"headLine05\">Audit support<\/h2>\n<p class=\"comTxt comTxt01\">CM Plus performs mock audits with our auditors who have experience of audits in Japan\/U.S.\/Europe or used to be the auditor at the authority. Based on the mock audits, we provide our clients with appropriate advices and proposals for improvement based on the client&#8217;s status of preparation. In addition, we provide support at backyard during audits and for handling observations provided after audits.<\/p>\n<ul class=\"comRaiList\">\n<li>Mock audits performed by our auditors who have experience of audits in Japan\/U.S.\/Europe or used to be the auditor at the authority (a simulation performed in the same way as the actual audits)<\/li>\n<li>Analysis of the current capability of our clients in terms of GMP audits and proposals for improvements<\/li>\n<li>Training for audit responders<\/li>\n<li>Providing support for preparing various documents and meeting with the authority<br class=\"wpTag\"><br \/>\n*Examples of our support for FDA audits: providing support for preparing packages for preliminary meetings (Type C Meeting) and attending meetings<\/li>\n<li>Giving advice at backyard during audits about preparation of materials and responses<\/li>\n<li>Providing support for preparing written agreements for making improvement in response to findings provided during an audit and for preparing written responses<\/li>\n<\/ul>\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/gmdp_consulting\/photo02.webp\" alt=\"Audit support\"><br \/>\n<span class=\"photoIco\"><br \/>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/gmdp_consulting\/photo02.webp\" class=\"popImg\">&nbsp;<\/a><br \/>\n<\/span>\n<\/div>\n<\/section>\n<section class=\"sec05 secBox\">\n<h2 class=\"headLine05\">GMDP ( GMP &amp; GDP ) Education\/Training Support<\/h2>\n<p class=\"comTxt comTxt01\">For drug production activities, it is important to give your employees effective education on GMDP continuously and make them understand GMDP correctly. CM Plus offers you &#8220;e-Learning&#8221; and &#8220;open seminars&#8221; for individuals, and &#8220;on-site seminars&#8221; for organizations.<\/p>\n<div class=\"comLinkPBox\">\n<p class=\"wpTag\">For e-learning, open seminars, and onsite seminars, please see our <a class=\"comTxtLink\" href=\"https:\/\/cm-plus.co.jp\/en\/service\/support_for_training\/\">\u201cEducation\/Training Support\u201d<\/a> section.<br class=\"wpTag\"><br \/>\nThe following link redirects to the GMP Platform we operate.<\/p>\n<ul class=\"flexC styleList\">\n<li class=\"comLinkP center\">\n<a href=\"https:\/\/www.gmp-platform.com\/seminar_list.html\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"subSpan\">List of \u201cOpen Seminars\u201d<\/span><\/a>\n<\/li>\n<li class=\"comLinkP center\">\n<a href=\"https:\/\/www.gmp-platform.com\/e-learning_list.html\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"subSpan\">Read more about \u201ce-Learning\u201d<\/span><\/a>\n<\/li>\n<\/ul>\n<\/div>\n<\/section>\n<section class=\"sec06 secBox\">\n<h2 class=\"headLine05\">Support for supplier control<\/h2>\n<p class=\"comTxt\">Experienced consultants provide support for quality audits (supplier audits)<br class=\"wpTag\"><br \/>\n\tWe can also support for audits of API\/drug formulation manufacturers and raw material\/packaging and labeling material suppliers.<\/p>\n<h3 class=\"headLine06\">A\uff1aSupport for the Implementation and Delegation of Domestic and Overseas Quality Audits<\/h3>\n<p class=\"comTxt\">CM Plus conducts quality audits together with you or on your behalf for contract manufacturers and suppliers of raw materials and materials. Our experts, with extensive consulting experience both domestically and internationally, handle these tasks. We support audits not only for domestic manufacturing sites but also for overseas manufacturing sites.<\/p>\n<h3 class=\"headLine06\">B\uff1aAuditor Training Support<\/h3>\n<p class=\"comTxt\">CM Plus offers educational training for beginners, newcomers and training supervisors to support the development and internal certification of auditors. For companies facing a shortage of audit personnel, our regularly held &#8220;GMP Auditor Training Program&#8221; has been well received. This program uses original, systematically designed materials created by experienced instructors and includes practical exercises (role-playing) simulating real-life scenarios as closely as possible.<\/p>\n<div class=\"comLinkPBox\">\n<p class=\"wpTag\">For information on the Auditor Training Program, please see our <a class=\"comTxtLink\" href=\"https:\/\/cm-plus.co.jp\/en\/service\/support_for_training\/\">\u201cEducation\/Training Support\u201d<\/a> section.<br class=\"pc\">The following is a link to the GMP Platform we operate.<\/p>\n<ul class=\"flexC\">\n<li class=\"comLinkP center\">\n<a href=\"https:\/\/www.gmp-platform.com\/seminar_detail.html?id=131\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"subSpan\">GMP Auditor Training Program<\/span><\/a>\n<\/li>\n<\/ul>\n<\/div>\n<\/section>\n<section class=\"sec07 secBox\">\n<h2 class=\"headLine05\">Other Services<\/h2>\n<h3 class=\"headLine06\">A\uff1aGMP for Investigational Medicinal Products (IMPs)<\/h3>\n<p class=\"comTxt\">CM Plus provides support for building a cGMP system for investigational medicinal products and for setting up Standard Operating Procedures (SOPs). This includes situations where biotech ventures and other companies completely outsource the manufacturing of their investigational compounds as they move into developmental stages.<\/p>\n<h3 class=\"headLine06\">B\uff1aGQP Operations Support<\/h3>\n<p class=\"comTxt\">Regarding GQP (Good Quality Practice), which is unique to Japanese regulations, our experienced consultants provide support for the establishment of GQP systems and the improvement of SOPs.<\/p>\n<\/section>\n<section class=\"sec08 secBox comBorBox\">\n<h2 class=\"headLine05\">Flow of Consulting<\/h2>\n<div class=\"comStepBox comStepBox02\">\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">01<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/icon_img07.webp\" alt=\"Inquiry from the corporate website\"><\/span><\/p>\n<h2 class=\"headLine06\">Inquiry from the corporate website<\/h2>\n<\/div>\n<p class=\"wpTag\">Please fill out the inquiry form.<\/p>\n<div class=\"comApplyLink\"><a href=\"https:\/\/cm-plus.co.jp\/en\/contact_us\/\"><span class=\"sub\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/icon-mail.webp\" width=\"20\" alt=\"Inquiry from the corporate website\">Click here to contact us.<\/span><\/a><\/div>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">02<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/icon_img08.webp\" alt=\"Online or On-site Meetings\"><\/span><\/p>\n<h2 class=\"headLine06\">Online or On-site Meetings<\/h2>\n<\/div>\n<p class=\"wpTag\">After listening to your requirements, we will introduce the services we can provide. Based on the information gathered, we will present a quotation and a specification sheet at a later date. If necessary, a confidentiality agreement will be concluded before the meeting.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">03<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/icon_img09.webp\" alt=\"Order and Contract\"><\/span><\/p>\n<h2 class=\"headLine06\">Order and Contract<\/h2>\n<\/div>\n<p class=\"wpTag\">If you are willing to place an order for our services and quotation conditions, we will either (1) issue a purchase order with a confidentiality agreement, or (2) enter into a business consignment agreement that includes confidentiality.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">04<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/icon_img10.webp\" alt=\"Consulting Implementation\"><\/span><\/p>\n<h2 class=\"headLine06\">Consulting Implementation<\/h2>\n<\/div>\n<p class=\"wpTag\">We will conduct actual consulting, such as GAP analysis, improvement support, and audit representation, either through on-site visits or online.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">05<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/icon_img11.webp\" alt=\"Submission of Reports and Documentation\"><\/span><\/p>\n<h2 class=\"headLine06\">Submission of Reports and Documentation<\/h2>\n<\/div>\n<p class=\"wpTag\">Based on the agreement with the client, we will submit consulting records, audit reports, and other related documentation.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\r\n\t<h2 class=\"headLine04\">Client Testimonials<\/h2>\r\n\t<ul class=\"comFooUl comCaseListSml flex\">\r\n\t\t\t\t\t<li>\r\n\t\t\t\t<a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/voice\/goryo\/\">\r\n\t\t\t\t\t<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/uploads\/2017\/07\/thumb_goryo.jpg\" alt=\"Goryo Chemical, Inc.\"><\/span>\r\n\t\t\t\t\t<span class=\"textBox\">\r\n\t\t\t\t\t\t<span class=\"tag\"><span class=\"wpTag\" style=\"background-color: #217870;\">Engineering<\/span><span class=\"wpTag\" style=\"background-color: #2b5273;\">Consulting<\/span><\/span>\t\t\t\t\t\t<span class=\"ttl\">From Pharmaceutical Regulations to QMS and GMP Consulting: Support with Consulting That Overcomes the High Barriers to Entry from Different Industries.<br \/>\r\n<\/span>\t\t\t\t\t\t<span class=\"txt02\">Goryo Chemical, Inc.<\/span>\r\n\t\t\t\t\t<\/span>\r\n\t\t\t\t<\/a>\r\n\t\t\t<\/li>\r\n\t\t\t<\/ul>\r\n<\/section>\r\n\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\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/div>\n<p><span class=\"subSpan\">Projects<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/about_cm_plus\/record\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/div>\n<p><span class=\"subSpan\">Performance by Numbers<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section>\n<h2 class=\"headLine04\">Other Services<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo01.webp\" alt=\"Engineering, Project Management\"><\/span><br \/>\n<span class=\"subSpan\">Engineering, Project Management<\/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\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo04.webp\" alt=\"Technical Information Services\"><\/div>\n<p><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 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href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/overseas_project_support\/partners_2\/\">Collaboration Partners in Europe and America<\/a><\/li>\n\t<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-266\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-266\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/\">Consulting<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-272\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-272\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/gmdp_consulting\/\">Pharmaceutical GMP &#038; GDP Consulting<\/a><\/li>\n\t<li id=\"menu-item-271\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-271\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/qms_consulting\/\">QMS for Medical Devices<\/a><\/li>\n\t<li id=\"menu-item-274\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-274\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/regulatory_affairs\/\">Regulatory Affairs Consulting<\/a><\/li>\n\t<li id=\"menu-item-267\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-267\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/qualification_validation\/\">Validation Consulting<\/a><\/li>\n\t<li id=\"menu-item-270\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-270\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/regenerative_medicine\/\">Regenerative Medicine Consulting<\/a><\/li>\n\t<li id=\"menu-item-273\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-273\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/contamination_control_strategy\/\">Contamination Control Strategy (CCS) Consulting<\/a><\/li>\n\t<li id=\"menu-item-5658\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5658\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/data_integrity\/\">Data Integrity (DI) Consulting<\/a><\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-277\" class=\"jsLi noChild menu-item menu-item-type-post_type menu-item-object-page menu-item-277\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/support_for_training\/\">Education\/Training Support<\/a><\/li>\n<li id=\"menu-item-275\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-275\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/\">Technical Information Services<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-1872\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1872\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/corressa\/\">CORRESSA<\/a><\/li>\n\t<li id=\"menu-item-5851\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5851\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/energy_management\/\">Energy Management Solutions \u201cCMP Way\u201d<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul><\/aside><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Home\/ Services\/ Consulting\/ Pharmaceutical GMP &amp; GDP Consulting ConsultingPharmaceutical GMP &amp; GDP Consulting Do you have any of these wishes regarding building in quality? We want to prepare for regulatory inspections. We want a partner who can concretely advance the construction\/improvement of quality systems. We want to eliminate concerns about problems and risks lurking in the manufacturing facility. We want personnel responsible for auditing external contractors\u2019 manufacturing plants and raw material suppliers. We want to efficiently establish a quality system in new business areas. With CM Plus\u2019s GMDP Consulting, we offer the following support for Regulatory inspections such as those by the FDA and PMDA: Mock inspections Inspection response training [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":155,"menu_order":51,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[11,8],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharmaceutical GMP &amp; GDP Consulting\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"Experienced consultants in various fields such as GMDP, QMS, and regulatory affairs support the quality creation of pharmaceuticals and medical devices.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/gmdp_consulting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmaceutical GMP &amp; 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