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Celltrion
<!DOCTYPE html> <html lang="en" class="en"> <head> <meta charset="utf-8"> <meta http-equiv="X-UA-Compatible" content="IE=edge, chrome=1"> <meta name="viewport" content="width=device-width, initial-scale=1.0, minimum-scale=1.0, maximum-scale=1.0, user-scalable=no, minimal-ui"> <meta name="format-detection" content="telephone=no"> <meta name="title" content="Celltrion" /> <meta name="author" content="Celltrion" /> <meta name="description" content="" /> <meta name="keywords" content=""> <title>Celltrion</title> <meta property="og:title" content="Celltrion"> <meta property="og:description" content=""> <meta property="og:url" content=""> <meta property="og:images" content=""> <meta property="og:type" content="website"> <link rel="shortcut icon" type="image/x-icon" href="/front/assets/common/images/common/favicon.ico"> <meta name="csrf_name" content="_csrf" /> <meta name="csrf_token" content="bb1eebbe-00bc-4163-b03f-db91dd793658" /> <link href="/front/assets/common/js/lib/jquery-ui.min.css" 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<dd> <a href="/en-us/company/media-center" title="Media Center">Media Center</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="BUSINESS">BUSINESS</a> <dl> <dd> <a href="/en-us/business/overview" title="Business Areas">Business Areas</a> </dd> <dd> <a href="/en-us/business/rnd" title="R&D">R&D</a> </dd> <dd> <a href="/en-us/business/production" title="Production">Production</a> </dd> <dd> <a href="/en-us/business/distribution" title="Distribution">Distribution</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="PRODUCTS">PRODUCTS</a> <dl> <dd> <a href="/en-us/products/approved" title="Products">Products</a> </dd> <dd> <a href="/en-us/products/pipelines" title="Pipeline">Pipeline</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="ESG">ESG</a> <dl> <dd> <a href="/en-us/esg/environment" title="Environmental">Environmental</a> </dd> <dd> <a href="/en-us/esg/society" title="Social">Social</a> </dd> <dd> <a href="/en-us/esg/governance" title="Governance">Governance</a> </dd> <dd> <a href="/en-us/esg/data-room" title="ESG Archive">ESG Archive</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="IR">IR</a> <dl> <dd> <a href="/en-us/investment/financial" title="Financial Information">Financial Information</a> </dd> <dd> <a href="/en-us/investment/stock-info" title="Stock Summary">Stock Summary</a> </dd> <dd> <a href="/en-us/investment/notice" title="Public Disclosures">Public Disclosures</a> </dd> <dd> <a href="/en-us/investment/ir" title="IR Archive">IR Archive</a> </dd> </dl> </li> <li> <a href="javascript:void(0);" title="CAREERS">CAREERS</a> <dl> <dd> <a href="/en-us/careers/talent" title="Our Values">Our Values</a> </dd> <dd> <a href="/en-us/careers/recruit" title="How to Apply">How to Apply</a> </dd> <dd class="outlink"> <a href="https://recruit.celltrion.com/CELLTRION.html" title="Jobs" target="_blank">Jobs</a> </dd> </dl> </li> </ul> <div class="languageWrap"> <div class="localLangSelector"> <ul> <li><a href="/ko-kr">KOR</a></li> <li class="active"><a href="/en-us">ENG</a></li> </ul> </div> <div class="globleLangSelector"> <button type="button" class="iconGlobalLanguage" title="Choose All Languages"><span class="blind">Choose All Languages</span></button> </div> </div> <div class="globleLangAll"> <div class="tabNavWrap language"> <ul class="tabNavList"> <li class="active"><a href="javascript:void(0);" title="Europe">Europe</a></li> <li><a href="javascript:void(0);" title="Asia Pacific">Asia Pacific</a></li> <li><a href="javascript:void(0);" title="North America">North America</a></li> <li><a href="javascript:void(0);" title="Latin America">Latin America</a></li> </ul> </div> <div class="tabContentsWrap"> <button type="button" class="iconallLanguageClose"><span class="blind">close</span></button> <div class="tabContents languageTab_01_cont_0 active"> <ul class="languageList"> <li><a href="https://celltrionhealthcare.fi/fi-fi/" target="_blank">Finland (FI)</a></li> <li><a href="https://celltrionhealthcare.fi/sv-fi/" target="_blank">Finland (SV)</a></li> <li><a href="https://www.celltrionhealthcare.fr/" target="_blank">France</a></li> <li><a href="https://www.celltrionhealthcare.de/" target="_blank">Germany</a></li> <li><a href="https://www.celltrionhealthcare.hu/" target="_blank">Hungary</a></li> <li><a href="https://www.celltrionhealthcare.ie/" target="_blank">Ireland</a></li> <li><a href="https://www.celltrionhealthcare.it/" target="_blank">Italy</a></li> <li><a href="https://www.celltrionhealthcare.nl/" target="_blank">Netherlands</a></li> <li><a href="https://www.celltrionhealthcare.com.tr/" target="_blank">Turkey</a></li> <li><a href="https://www.celltrionhealthcare.co.uk/" target="_blank">United Kingdom</a></li> </ul> </div> <div class="tabContents languageTab_01_cont_1"> <ul class="languageList"> <li><a href="https://www.celltrion.com/ko-kr" target="_blank">Korea (HQ)</a></li> <li><a href="https://www.celltrion.com/en-us" target="_blank">Korea (EN)</a></li> <li><a href="https://www.celltrionhealthcare.jp/" target="_blank">Japan</a></li> <li><a href="https://celltrionhealthcare.com.au/" target="_blank">Australia</a></li> </ul> </div> <div class="tabContents languageTab_01_cont_2"> <ul class="languageList"> <li><a href="https://www.celltrionhealthcare.ca/" target="_blank">Canada (EN)</a></li> <li><a href="https://www.celltrionhealthcare.ca/fr-ca/" target="_blank">Canada (FR)</a></li> <li><a href="https://www.celltrionusa.com/" target="_blank">USA</a></li> </ul> </div> <div class="tabContents languageTab_01_cont_3"> <ul class="languageList"> <li><a href="https://www.celltrionhealthcare.com.br/" target="_blank">Brazil</a></li> <li><a href="https://celltrionhealthcare.com.co/" target="_blank">Colombia</a></li> <li><a href="https://www.celltrionhealthcare.cl/" target="_blank">Chile</a></li> <li><a href="https://celltrionhealthcare.com.pe/" target="_blank">Peru</a></li> <li><a href="https://celltrionhealthcare.mx/" target="_blank">Mexico</a></li> </ul> </div> </div> </div> </article> <div class="mobileAllMenu"> <button type="button" class="iconMobileAllMenu"><span class="blind">full menu</span></button> </div> </section> </header> <div class="cpnt_breadcrumb"> <ol> <li> <a href="/en-us">HOME</a> </li> <li> <button type="button">BUSINESS</button> <ul> <li> <a href="/en-us/company">ABOUT US</a> </li> <li> <a href="/en-us/business">BUSINESS</a> </li> <li> <a href="/en-us/products">PRODUCTS</a> </li> <li> <a href="/en-us/esg">ESG</a> </li> <li> <a href="/en-us/investment">IR</a> </li> <li> <a href="/en-us/careers">CAREERS</a> </li> </ul> </li> <li> <button type="button">Production</button> <ul> <li> <a href="/en-us/business/overview">Business Areas</a> </li> <li> <a href="/en-us/business/rnd">R&D</a> </li> <li> <a href="/en-us/business/production">Production</a> </li> <li> <a href="/en-us/business/distribution">Distribution</a> </li> </ul> </li> <li> <button type="button">Quality Management</button> <ul> <li> <a href="/en-us/business/production/facilities">Production Facilities</a> </li> <li> <a href="/en-us/business/production/quality-controls">Quality Management</a> </li> <li> <a href="/en-us/business/production/cmo-cdmo">CDMO</a> </li> </ul> </li> </ol> </div> <main id="wrapper"> <section class="business qc"> <article class="innerContentsWrap "> <div class="contentsWrap"> <div class="contentsHead"> <h2>Production</h2> </div> <div class="contentsBody"> <div class="tabNavWrap type_01" data-aos="fade-up" data-aos-easing="ease" data-aos-duration="500" data-aos-once="true" data-aos-offset="300"> <ul class="tabNavList"> <li> <a href="/en-us/business/production/facilities" title="Production Facilities">Production Facilities</a> </li> <li class="active"> <a href="/en-us/business/production/quality-controls" title="Quality Management">Quality Management</a> </li> <li> <a href="/en-us/business/production/cmo-cdmo" title="CDMO">CDMO</a> </li> </ul> </div> </div> </div> </article> <article class="innerVisualWrap roundMotion"> <img src="/front/assets/common/images/business/img_qc_keyvisual.png" alt="main"> <img src="/front/assets/common/images/business/img_qc_mkeyvisual.png" alt="main"> </article> <article class="innerContentsWrap"> <div class="contentsWrap"> <div class="contentsBody mobileMotion"> <div class="business_qc-content"> <div class="business_qc-item"> <div class="qc-title"> <div class="font-3125">Celltrion implements a strict quality policy that complies with the latest global GMP regulations</div> </div> <div class="qc-content"> <div class="qc-item-ctn"> <div class="qc-item-box"> <div class="qc-txt-box"> <span class="font-0875">01</span> <div class="font-3125">Plan</div> <ul class="font-1125-list"> <li class="font-1125">Risk assessment analysis</li> <li class="font-1125">Resource analysis</li> <li class="font-1125">Strategic analysis</li> </ul> </div> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc02.png" alt="qc1"> </div> <div class="qc-txt-box"> <span class="font-0875">03</span> <div class="font-3125">Monitoring</div> <ul class="font-1125-list"> <li class="font-1125">Internal audit</li> <li class="font-1125">Trend monitoring</li> <li class="font-1125">Deviation/change control</li> </ul> </div> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc04.png" alt="qc1"> </div> <div class="qc-txt-box"> <span class="font-0875">05</span> <div class="font-3125">Improvement</div> <ul class="font-1125-list"> <li class="font-1125">Immediate improvement</li> <li class="font-1125">Corrective Action & </li> <li class="font-1125">Preventative Action (CAPA)</li> <li class="font-1125">Procedure update</li> </ul> </div> </div> <div class="qc-line-box"> <div class="qc-line"> <div class="qc-line_on"> <div class="pointer"></div> </div> </div> </div> <div class="qc-item-box qc_left"> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc01.png" alt="qc1"> </div> <div class="qc-txt-box"> <span class="font-0875">02</span> <div class="font-3125">Performance</div> <ul class="font-1125-list"> <li class="font-1125">Education, documentation</li> <li class="font-1125">Validation, calibration</li> <li class="font-1125">Execution</li> </ul> </div> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc03.png" alt="qc1"> </div> <div class="qc-txt-box"> <span class="font-0875">04</span> <div class="font-3125">Evaluation</div> <ul class="font-1125-list"> <li class="font-1125">Convene quality council</li> <li class="font-1125">Trend analysis</li> <li class="font-1125">Regulatory inspections</li> <li class="font-1125">Product quality review</li> </ul> </div> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc05.png" alt="qc1"> </div> </div> </div> <div class="qc-item-ctn_mo"> <div class="qc-line-mo-box"> <div class="qc-line-mo"> <div class="qc-line-mo_on"> <div class="pointer"></div> </div> </div> </div> <div class="qc-item-box_mo"> <div class="qc-txt-box"> <span class="font-0875">01</span> <div class="font-3125">Plan</div> <ul class="font-1125-list"> <li class="font-1125">Risk assessment analysis</li> <li class="font-1125">Resource analysis</li> <li class="font-1125">Strategic analysis</li> </ul> </div> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc01.png" alt="qc1"> </div> <div class="qc-txt-box"> <span class="font-0875">02</span> <div class="font-3125">Performance</div> <ul class="font-1125-list"> <li class="font-1125">Education, documentation</li> <li class="font-1125">Validation, calibration</li> <li class="font-1125">Execution</li> </ul> </div> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc02.png" alt="qc1"> </div> <div class="qc-txt-box"> <span class="font-0875">03</span> <div class="font-3125">Monitoring</div> <ul class="font-1125-list"> <li class="font-1125">Internal audit</li> <li class="font-1125">Trend monitoring</li> <li class="font-1125">Deviation/change control</li> </ul> </div> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc03.png" alt="qc1"> </div> <div class="qc-txt-box"> <span class="font-0875">04</span> <div class="font-3125">Evaluation</div> <ul class="font-1125-list"> <li class="font-1125">Convene quality council</li> <li class="font-1125">Trend analysis</li> <li class="font-1125">Regulatory inspections</li> <li class="font-1125">Product quality review</li> </ul> </div> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc04.png" alt="qc1"> </div> <div class="qc-txt-box"> <span class="font-0875">05</span> <div class="font-3125">Improvement</div> <ul class="font-1125-list"> <li class="font-1125">Immediate improvement</li> <li class="font-1125">Corrective Action & </li> <li class="font-1125">Preventative Action (CAPA)</li> <li class="font-1125">Procedure update</li> </ul> </div> <div class="qc-img-box"> <img class="qc_img" src="/front/assets/common/images/business/img_qc05.png" alt="qc1"> </div> </div> </div> </div> </div> <div class="business_qc-item_sub"> <div class="qc-item-box"> <div class="font-1188">Quality Policy</div> <div class="font-25">Celltrion does not Compromise on Quality</div> <div class="font-25_mo">Celltrion does not Compromise on Quality.</div> <div class="qc-img-box"> <div class="qc-img-box-list"> <img class="qc_img_sub" src="/front/assets/common/images/business/img_qc06.png" alt="sub"> <div class="qc-img-txt-list t-1"> <div class="font-1125">All products, processes, procedures, methods, and</div> <div class="font-1125">services at Celltrion must be managed in a way that ensures consistently high levels of quality</div> <div class="font-1125_mo"> All products, processes, procedures, methods, and services at Celltrion must be managed in a way that ensures consistently high levels of quality </div> </div> </div> <div class="qc-img-box-list t-1"> <img class="qc_img_sub" src="/front/assets/common/images/business/img_qc07.png" alt="sub"> <div class="qc-img-txt-list"> <div class="font-1125">Celltrion quality system must meet or exceed the quality </div> <div class="font-1125">requirement of world-wide pharmaceutical regulatory</div> <div class="font-1125">bodies and industries as defined by world-wide GMPs</div> <div class="font-1125_mo"> Celltrion quality system must meet or exceed the quality requirement of world-wide pharmaceutical regulatory bodies and industries as defined by world-wide GMPs </div> </div> </div> <div class="qc-img-box-list t-1"> <img class="qc_img_sub" src="/front/assets/common/images/business/img_qc08.png" alt="sub"> <div class="qc-img-txt-list"> <div class="font-1125">Celltrion Quality System must place quality above all</div> <div class="font-1125">other goals to ensure consistent product quality and</div> <div class="font-1125">manufacturing processes at all times.</div> <div class="font-1125_mo"> Celltrion Quality System must place quality above all other goals to ensure consistent product quality and manufacturing processes at all times. </div> </div> </div> </div> </div> <div class="qc-item-box"> <div class="font-15">Celltrion is striving not only to maintain the superior quality of all products but also to improve the quality through</div> <div class="font-15"><strong>establishing and complying with strict quality policies and procedures.</strong></div> <div class="font-15_mo pt1 pb1">Celltrion is striving not only to maintain the superior quality of all products but also to improve the quality through <strong>establishing and complying with Celltrion-specific policies and procedures.</strong></div> </div> <div class="qc-item-box"> <div class="font-25">Quality <br class="pc" /> Management <br class="pc" /> System</div> <div class="qc-txt-box"> <div class="font-1125"> Celltrion carries out risk assessment of possible factors that may have an impact on the quality, safety and efficacy of the products by applying ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality System to the scientific information and data that have been verified and accumulated throughout the product development and process. CQA(Critical Quality Attribute) and CPP(Critical Process Parameter), which may affect the quality of our products, are set, monitored, and improved. We are continually striving for consistently superior quality as well as quality improvement. </div> </div> </div> <div class="qc-item-box"> <div class="font-25">Quality Level</div> <div class="qc-txt-box"> <img class="qc_img_sub" src="/front/assets/common/images/business/img_qc09.png" alt="sub"> <img class="qc_img_sub_mo" src="/front/assets/common/images/business/img_qc09_mo.png" alt="sub"> <div class="font-1125"> The high-standard quality policies at Celltrion have allowed a continuance of near 100% high-quality production records as well as a long, proud history of contamination-free and accident-free production records. The level of quality at Celltrion regarding facilities, process, and quality systems are put through regulatory inspections for adequate control by the regulatory authorities in various countries. Moreover, all employees receive thorough training on documentation management and risk factor monitoring. The global quality operation group composed of outstanding quality management specialists, as well as a separate corporate audit team, are doing their best to maintain consistently superior product quality. </div> </div> </div> </div> </div> <div class="leadMoreWrap intervalTop"> <h4>Read More</h4> <ul class="pageList"> <li> <a href="/en-us/business/production/facilities" title="Production Facilities"><span>Production Facilities</span></a> <img src="/front/assets/common/images/business/img_pl_more.png" alt=""> </li> <li> <a href="/en-us/business/production/cmo-cdmo" title="CDMO"><span>CDMO</span></a> <img src="/front/assets/common/images/business/img_cc_more.png" alt=""> </li> </ul> </div> </div> </div> </article> </section> </main> <footer id="footer"> <section class="innerWrap"> <div class="footerTopBtn"> <button type="button" class="iconGoToTop" title="Top scroll"><span class="blind">Top button</span></button> </div> <article id="footerWrap"> <ul class="menu"> <li> <dl> <dt> <a href="javascript:void(0);" title="ABOUT US">ABOUT US</a> </dt> <dd> <a href="/en-us/company/celltrion" title="About Celltrion">About Celltrion</a> </dd> <dd> <a href="/en-us/company/notice" title="Notice">Notice</a> </dd> <dd> <a href="/en-us/company/media-center" title="Media Center">Media Center</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="BUSINESS">BUSINESS</a> </dt> <dd> <a href="/en-us/business/overview" title="Business Areas">Business Areas</a> </dd> <dd> <a href="/en-us/business/rnd" title="R&D">R&D</a> </dd> <dd> <a href="/en-us/business/production" title="Production">Production</a> </dd> <dd> <a href="/en-us/business/distribution" title="Distribution">Distribution</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="PRODUCTS">PRODUCTS</a> </dt> <dd> <a href="/en-us/products/approved" title="Products">Products</a> </dd> <dd> <a href="/en-us/products/pipelines" title="Pipeline">Pipeline</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="ESG">ESG</a> </dt> <dd> <a href="/en-us/esg/environment" title="Environmental">Environmental</a> </dd> <dd> <a href="/en-us/esg/society" title="Social">Social</a> </dd> <dd> <a href="/en-us/esg/governance" title="Governance">Governance</a> </dd> <dd> <a href="/en-us/esg/data-room" title="ESG Archive">ESG Archive</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="IR">IR</a> </dt> <dd> <a href="/en-us/investment/financial" title="Financial Information">Financial Information</a> </dd> <dd> <a href="/en-us/investment/stock-info" title="Stock Summary">Stock Summary</a> </dd> <dd> <a href="/en-us/investment/notice" title="Public Disclosures">Public Disclosures</a> </dd> <dd> <a href="/en-us/investment/ir" title="IR Archive">IR Archive</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="CAREERS">CAREERS</a> </dt> <dd> <a href="/en-us/careers/talent" title="Our Values">Our Values</a> </dd> <dd> <a href="/en-us/careers/recruit" title="How to Apply">How to Apply</a> </dd> <dd class="outlink"> <a href="https://recruit.celltrion.com/CELLTRION.html" title="Jobs" target="_blank">Jobs</a> </dd> </dl> </li> </ul> <div class="familySite"> <div class="inputSelect dark"> <select id="familySiteSelector" class="selector"> <option>Family Site</option> <option value="https://www.celltrionph.com/en-us/home/index">Celltrion Pharm</option> <option value="https://www.celltrionbeauty.com">Celltrion Skincure</option> <option value="https://www.celltrionwelfare.com">Celltrion Welfare</option> <option value="https://celltrionenter.com">Celltrion Ent.</option> </select> </div> </div> <div class="logo"><span class="blind">Celltrion</span></div> <ul class="sideMenu"> <li><a href="/en-us/terms/privacy-policy" title="Privacy Policy">Privacy Policy</a></li> <li><a href="/en-us/terms/legal-notice" title="Legal Notice">Legal Notice</a></li> <li><a href="/en-us/terms/import-export-policy" title="Export and Import Management Policy">Export and Import Management Policy</a></li> <li><a href="/en-us/contact/inquiry" title="Contact Us">Contact Us</a></li> <li><a href="/en-us/contact/directions" title="Directions">Directions</a></li> </ul> <address>23, Academy-ro, Yeonsu-gu, Incheon, Republic of Korea<span>+82-32-850-5000</span><p>© CELLTRION INC. 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