{"id":5891,"date":"2023-10-15T09:54:44","date_gmt":"2023-10-15T04:24:44","guid":{"rendered":"https:\/\/pharmaceuticalcarrier.com\/?p=5891"},"modified":"2023-10-15T12:22:58","modified_gmt":"2023-10-15T06:52:58","slug":"standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy","status":"publish","type":"post","link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/","title":{"rendered":"Standard Operating Procedure (SOP) for Calibrating and Verifying HPLC System Accuracy"},"content":{"rendered":"\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-transparent ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#1_Purpose_of_Calibrating_and_Verifying_HPLC_System_Accuracy\" >1. Purpose of Calibrating and Verifying HPLC System Accuracy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#2_Scope_of_Calibrating_and_Verifying_HPLC_System_Accuracy\" >2. Scope of Calibrating and Verifying HPLC System Accuracy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#3_Definitions_involved_in_Calibrating_and_Verifying_HPLC_System_Accuracy\" >3. Definitions involved in Calibrating and Verifying HPLC System Accuracy<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#31_HPLC_System\" >3.1 HPLC System:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#32_Calibration\" >3.2 Calibration:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#4_Responsibilities\" >4. Responsibilities<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#41_Laboratory_Manager\" >4.1. Laboratory Manager<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#42_Calibration_Technician\" >4.2. Calibration Technician<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#5_Calibration_and_Verification_Procedures\" >5. Calibration and Verification Procedures<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#51_Pre-Calibration_Preparations\" >5.1. Pre-Calibration Preparations<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#52_Calibration_Equipment\" >5.2. Calibration Equipment<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#53_Calibration_Steps\" >5.3. Calibration Steps<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#54_Calibration_Report\" >5.4. Calibration Report<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#6_Record_Keeping\" >6. Record Keeping<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#61_Calibration_Records\" >6.1. Calibration Records<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2023\/10\/15\/standard-operating-procedure-sop-for-calibrating-and-verifying-hplc-system-accuracy\/#62_Schedule\" >6.2. Schedule<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_Purpose_of_Calibrating_and_Verifying_HPLC_System_Accuracy\"><\/span><strong>1. Purpose of Calibrating and Verifying HPLC System Accuracy<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for calibrating and verifying the accuracy of HPLC systems at [Company Name]. This procedure ensures that the HPLC system operates within defined parameters, maintaining the precision and reliability of analytical results.<\/p><div class=\"pharm-content\" id=\"pharm-541115122\"><script async src=\"\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-8402705006112223\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display:block;\" data-ad-client=\"ca-pub-8402705006112223\" \ndata-ad-slot=\"7652789694\" \ndata-ad-format=\"auto\"><\/ins>\n<script> \n(adsbygoogle = window.adsbygoogle || []).push({}); \n<\/script>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_Scope_of_Calibrating_and_Verifying_HPLC_System_Accuracy\"><\/span><strong>2. Scope of Calibrating and Verifying HPLC System Accuracy<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>This SOP applies to all personnel responsible for the calibration and accuracy verification of HPLC systems within [Company Name]. It encompasses the calibration of the entire system, including pumps, detectors, and associated components.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_Definitions_involved_in_Calibrating_and_Verifying_HPLC_System_Accuracy\"><\/span><strong>3. Definitions involved in Calibrating and Verifying HPLC System Accuracy<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"31_HPLC_System\"><\/span>3.1 <strong>HPLC System<\/strong>: <span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>High-Performance Liquid Chromatography system used for the separation and analysis of compounds.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"32_Calibration\"><\/span>3.2 <strong>Calibration<\/strong>: <span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>The process of setting and verifying the precision and accuracy of the HPLC system.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"4_Responsibilities\"><\/span><strong>4. Responsibilities<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"41_Laboratory_Manager\"><\/span><strong>4.1. Laboratory Manager<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>4.1.1 Ensure that all HPLC systems in the laboratory are calibrated and verified as per the defined schedule.<\/p>\n\n\n\n<p>4.1.2 Allocate resources for calibration activities.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"42_Calibration_Technician\"><\/span><strong>4.2. Calibration Technician<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>4.2.1 Perform the calibration and accuracy verification of HPLC systems as per the defined schedule.<\/p>\n\n\n\n<p>4.2.2 Record and report calibration results.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"5_Calibration_and_Verification_Procedures\"><\/span><strong>5. Calibration and Verification Procedures<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"51_Pre-Calibration_Preparations\"><\/span><strong>5.1. Pre-Calibration Preparations<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>5.1.1 Notify users about the upcoming calibration.<\/p>\n\n\n\n<p>5.1.2 Ensure that the HPLC system is clean and free from any residues.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"52_Calibration_Equipment\"><\/span><strong>5.2. Calibration Equipment<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>5.2.1 Use calibrated standards and reference materials for calibration.<\/p>\n\n\n\n<p>5.2.2 Ensure that calibration equipment is traceable to national standards.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"53_Calibration_Steps\"><\/span><strong>5.3. Calibration Steps<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>5.3.1 Set up the HPLC system with the calibration equipment.<\/p>\n\n\n\n<p>5.3.2 Calibrate the pump flow rate and verify it with standard solutions.<\/p>\n\n\n\n<p>5.3.3 Calibrate the detector response with reference compounds.<\/p>\n\n\n\n<p>5.3.4 Verify the temperature control accuracy.<\/p>\n\n\n\n<p>5.4.5 Perform system suitability tests.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"54_Calibration_Report\"><\/span><strong>5.4. Calibration Report<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>5.4.1 Prepare a comprehensive calibration report detailing the HPLC system&#8217;s performance.<\/p>\n\n\n\n<p>5.4.2 Include a statement of calibration and results, including deviations and adjustments made.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"6_Record_Keeping\"><\/span><strong>6. Record Keeping<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"61_Calibration_Records\"><\/span><strong>6.1. Calibration Records<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>6.1.1 Maintain detailed calibration records for each HPLC system.<\/p>\n\n\n\n<p>6.1.2 Include calibration certificates, reports, and system suitability test results.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"62_Schedule\"><\/span><strong>6.2. Schedule<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>6.2.1 Establish a calibration schedule for HPLC systems.<\/p>\n\n\n\n<p>6.2.2 Ensure that the schedule is consistently followed.<\/p>\n\n\n\n<p>For more articles,&nbsp;<strong><a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/ayurveda\/\">Kindly Click<\/a>&nbsp;here<\/strong>.<\/p>\n\n\n\n<p>For pharmaceutical jobs, follow us on<strong>&nbsp;<a href=\"https:\/\/www.linkedin.com\/company\/pharmaceuticalcarrier\/?viewAsMember=true\" target=\"_blank\" rel=\"noreferrer noopener\">LinkedIn<\/a><\/strong>&nbsp;<\/p>\n\n\n\n<p><strong>For Editable SOPs in word format contact us on&nbsp;<a href=\"mailto:info@pharmaceuticalcarrier.com\">info@pharmaceuticalcarrier.com<\/a><\/strong>&nbsp;<\/p>\n\n\n\n<p>For more information kindly follow us on pharmaguidelines.co.uk<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Explore a comprehensive Standard Operating Procedure (SOP) for calibrating and verifying the accuracy of HPLC (High-Performance Liquid Chromatography) systems. This detailed SOP outlines the responsibilities, calibration procedures, and record-keeping necessary to ensure the precise and reliable operation of HPLC equipment, meeting quality standards and regulatory compliance.<\/p>\n","protected":false},"author":1,"featured_media":5599,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","footnotes":""},"categories":[165],"tags":[714,465,816,729,871,870,257,829,837,868,167,872],"class_list":["post-5891","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-standard-operating-procedure","tag-accuracy-verification","tag-calibration","tag-calibration-technician","tag-hplc","tag-laboratory","tag-laboratory-manager","tag-quality-control","tag-record-keeping-2","tag-reference-materials","tag-revision-history","tag-standard-operating-procedure","tag-system-suitability-tests"],"uagb_featured_image_src":{"full":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure.jpg",1200,720,false],"thumbnail":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure-150x150.jpg",150,150,true],"medium":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure-300x180.jpg",300,180,true],"medium_large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure-768x461.jpg",640,384,true],"large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure-1024x614.jpg",640,384,true],"1536x1536":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure.jpg",1200,720,false],"2048x2048":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure.jpg",1200,720,false],"authorship-box-avatar":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure-150x150.jpg",150,150,true],"authorship-box-related":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure-70x70.jpg",70,70,true],"sow-carousel-default":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2023\/09\/Standard-operating-procedure.jpg",272,163,false]},"uagb_author_info":{"display_name":"Pharmacareer","author_link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/author\/grandirpharmagmail-com\/"},"uagb_comment_info":1,"uagb_excerpt":"Explore a comprehensive Standard Operating Procedure (SOP) for calibrating and verifying the accuracy of HPLC (High-Performance Liquid Chromatography) systems. This detailed SOP outlines the responsibilities, calibration procedures, and record-keeping necessary to ensure the precise and reliable operation of HPLC equipment, meeting quality standards and regulatory compliance.","amp_enabled":true,"_links":{"self":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/5891","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/comments?post=5891"}],"version-history":[{"count":1,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/5891\/revisions"}],"predecessor-version":[{"id":5892,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/5891\/revisions\/5892"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media\/5599"}],"wp:attachment":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media?parent=5891"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/categories?post=5891"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/tags?post=5891"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}