{"id":7089,"date":"2024-02-26T17:41:48","date_gmt":"2024-02-26T12:11:48","guid":{"rendered":"https:\/\/pharmaceuticalcarrier.com\/?p=7089"},"modified":"2024-04-11T15:48:46","modified_gmt":"2024-04-11T10:18:46","slug":"standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2","status":"publish","type":"post","link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/","title":{"rendered":"Standard Operating Procedure (SOP) for Calibration of HPLC (High-Performance Liquid Chromatograph)"},"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\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#1_Purpose\" >1. Purpose:<\/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\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#2_Scope\" >2. Scope:<\/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\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#3_Responsibilities\" >3. Responsibilities:<\/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\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#31_Analyst\" >3.1. Analyst:<\/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\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#32_Laboratory_Manager\" >3.2. Laboratory Manager:<\/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\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#4_Materials_and_Equipment\" >4. Materials and Equipment:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#5_Calibration_Frequency\" >5. Calibration Frequency:<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#51_Factors_Influencing_Calibration_Frequency\" >5.1 Factors Influencing Calibration Frequency:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#52_Recommended_Calibration_Frequency\" >5.2. Recommended Calibration Frequency:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#53_Procedure_for_Adjusting_Calibration_Frequency\" >5.3. Procedure for Adjusting Calibration Frequency:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#6_Calibration_Procedure\" >6. Calibration Procedure:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#7_Documentation\" >7. Documentation:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#8_Training\" >8. Training:<\/a><\/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\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#9_References\" >9. References:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#10_Review\" >10. Review:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/#11_Approval\" >11. Approval:<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_Purpose\"><\/span><strong>1. Purpose:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>1.1 To ensure the accuracy and reliability of High-Performance Liquid Chromatography (HPLC) results. <\/p><div class=\"pharm-content\" id=\"pharm-622918168\"><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<p>1.2. To maintain compliance with regulatory requirements.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_Scope\"><\/span><strong>2. Scope:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>2.1. Applicable to all HPLC instruments in the laboratory. <\/p>\n\n\n\n<p>2.2. Covers calibration procedures for low-pressure quaternary gradient liquid chromatographs.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_Responsibilities\"><\/span><strong>3. 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=\"31_Analyst\"><\/span>3.1. Analyst: <span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Responsibilities of the Analyst:<\/strong><\/p>\n\n\n\n<p><strong>3.1. Preparation:<\/strong> <\/p>\n\n\n\n<p>3.1.1. Review the calibration schedule to ensure awareness of upcoming activities. <\/p>\n\n\n\n<p>3.1.2. Gather all necessary materials and standards required for the calibration. <\/p>\n\n\n\n<p>3.1.3. Verify the availability and proper functioning of the required equipment.<\/p>\n\n\n\n<p><strong>3.2. Initial System Check:<\/strong> <\/p>\n\n\n\n<p>3.2.1. Power on the HPLC instrument and allow it to stabilize for at least 30 minutes. <\/p>\n\n\n\n<p>3.2.2. Verify the proper installation of the column and the condition of mobile phase solutions. <\/p>\n\n\n\n<p>3.2.3. Check for any visible leaks or abnormalities in the system.<\/p>\n\n\n\n<p><strong>3.3. Instrument Verification:<\/strong> <\/p>\n\n\n\n<p>3.3.1. Perform an initial system suitability test using a standard sample. <\/p>\n\n\n\n<p>3.3.2. Verify and document the system parameters, including flow rate, pressure, and temperature. <\/p>\n\n\n\n<p>3.3.3. Communicate any irregularities to the supervisor or maintenance personnel.<\/p>\n\n\n\n<p><strong>3.4. Detector Calibration:<\/strong> <\/p>\n\n\n\n<p>3.4.1. Inject a standard solution and optimize detector parameters. <\/p>\n\n\n\n<p>3.4.2. Confirm the accuracy of the wavelength using a certified standard. <\/p>\n\n\n\n<p>3.4.3. Record all detector settings and any adjustments made during calibration.<\/p>\n\n\n\n<p><strong>3.5. Flow Rate Calibration:<\/strong> <\/p>\n\n\n\n<p>3.5.1. Utilize a calibrated flowmeter to measure the actual flow rate. <\/p>\n\n\n\n<p>3.5.2. Adjust the flow rate settings on the instrument based on the measurements. <\/p>\n\n\n\n<p>3.5.3. Document all adjustments made during flow rate calibration.<\/p>\n\n\n\n<p><strong>3.6. Pressure Calibration:<\/strong> <\/p>\n\n\n\n<p>3.6.1. Connect a calibrated pressure gauge to the system. <\/p>\n\n\n\n<p>3.6.2. Compare the gauge reading with the instrument display. <\/p>\n\n\n\n<p>3.6.3. Collaborate with maintenance if pressure adjustments are required and document changes.<\/p>\n\n\n\n<p><strong>3.7. System Suitability Testing:<\/strong> <\/p>\n\n\n\n<p>3.7.1. Run a system suitability test using a standard mixture. <\/p>\n\n\n\n<p>3.7.2. Monitor peak resolution and retention times, ensuring they meet acceptance criteria. <\/p>\n\n\n\n<p>3.7.3. Document all results and report any deviations to the supervisor.<\/p>\n\n\n\n<p><strong>3.8. Documentation:<\/strong> <\/p>\n\n\n\n<p>3.8.1. Record all calibration data, observations, and adjustments in the calibration logbook. <\/p>\n\n\n\n<p>3.8.2. Ensure that entries are clear, complete, and compliant with established procedures.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"32_Laboratory_Manager\"><\/span>3.2. Laboratory Manager: <span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>3.1. Planning and Coordination:<\/strong> <\/p>\n\n\n\n<p>3.1.1. Develop and maintain a comprehensive calibration schedule for all HPLC instruments. <\/p>\n\n\n\n<p>3.1.2. Coordinate with analysts to ensure adequate resources, including standards and equipment, are available for calibration. <\/p>\n\n\n\n<p>3.1.3. Review and approve the calibration plan before implementation.<\/p>\n\n\n\n<p><strong>3.2. Resource Management:<\/strong> <\/p>\n\n\n\n<p>3.2.1. Ensure that all necessary standards, reagents, and equipment are in stock and meet quality standards. <\/p>\n\n\n\n<p>3.2.2. Oversee the proper storage and handling of calibration materials to prevent contamination or degradation. <\/p>\n\n\n\n<p>3.2.3. Allocate resources efficiently to minimize downtime during calibration activities.<\/p>\n\n\n\n<p><strong>3.3. Training and Qualification:<\/strong> <\/p>\n\n\n\n<p>3.3.1. Ensure that analysts involved in the calibration process are adequately trained. <\/p>\n\n\n\n<p>3.3.2. Verify that analysts have the necessary qualifications and certifications to perform calibration tasks. 3.3.3. Facilitate ongoing training and professional development for the calibration team.<\/p>\n\n\n\n<p><strong>3.4. Oversight of Calibration Activities:<\/strong> <\/p>\n\n\n\n<p>3.4.1. Review and approve the initial system checks performed by analysts. <\/p>\n\n\n\n<p>3.4.2. Verify that instrument verification, detector calibration, flow rate calibration, and pressure calibration are conducted according to SOPs. <\/p>\n\n\n\n<p>3.4.3. Monitor and address any deviations or issues during the calibration process.<\/p>\n\n\n\n<p><strong>3.5. Documentation Review:<\/strong> <\/p>\n\n\n\n<p>3.5.1. Regularly review calibration logbooks for completeness, accuracy, and adherence to established procedures. <\/p>\n\n\n\n<p>3.5.2. Verify that all necessary signatures and approvals are documented before closing out calibration records. <\/p>\n\n\n\n<p>3.5.3. Investigate and address any discrepancies or non-compliance issues.<\/p>\n\n\n\n<p><strong>3.6. Continuous Improvement:<\/strong> <\/p>\n\n\n\n<p>3.6.1. Periodically assess the effectiveness of the calibration process. <\/p>\n\n\n\n<p>3.6.2. Identify opportunities for improvement and implement corrective actions. <\/p>\n\n\n\n<p>3.6.3. Collaborate with the Quality Assurance team to enhance calibration procedures and ensure compliance with industry standards.<\/p>\n\n\n\n<p><strong>3.7. Communication:<\/strong> <\/p>\n\n\n\n<p>3.7.1. Communicate calibration results and any significant findings to relevant stakeholders. <\/p>\n\n\n\n<p>3.7.2. Ensure that necessary corrective actions are communicated and implemented in a timely manner. 3.7.3. Facilitate a culture of open communication within the calibration team.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"4_Materials_and_Equipment\"><\/span><strong>4. Materials and Equipment:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>4.1. HPLC instrument. <\/p>\n\n\n\n<p>4.2. Certified calibration standards. <\/p>\n\n\n\n<p>4.3. Mobile phase solutions. <\/p>\n\n\n\n<p>4.4. Analytical balance. <\/p>\n\n\n\n<p>4.5. Certified glassware. <\/p>\n\n\n\n<p>4.6. Calibration logbook.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"5_Calibration_Frequency\"><\/span><strong>5. Calibration Frequency:<\/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_Factors_Influencing_Calibration_Frequency\"><\/span>5.1 <strong>Factors Influencing Calibration Frequency:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>5.1 <strong>Manufacturer Recommendations:<\/strong> <\/p>\n\n\n\n<p>5.1.1. Refer to the manufacturer&#8217;s guidelines for the recommended calibration frequency. <\/p>\n\n\n\n<p>5.1.2. Take into consideration any specific requirements or recommendations provided by the HPLC instrument manufacturer.<\/p>\n\n\n\n<p>5.<strong>2. Regulatory Requirements:<\/strong> <\/p>\n\n\n\n<p>5.2.1. Ensure compliance with relevant regulatory standards and guidelines. <\/p>\n\n\n\n<p>5.2.2. Determine if regulatory bodies prescribe specific calibration intervals for HPLC instruments used in the laboratory.<\/p>\n\n\n\n<p>5.<strong>.3. Instrument Usage:<\/strong> <\/p>\n\n\n\n<p>5.3.1. Consider the frequency and intensity of use for each HPLC instrument. <\/p>\n\n\n\n<p>5.3.2. Instruments used more frequently or for critical analyses may require more frequent calibration.<\/p>\n\n\n\n<p>5.<strong>4. Historical Performance:<\/strong> <\/p>\n\n\n\n<p>5.4.1. Review historical calibration records to identify any patterns or trends. <\/p>\n\n\n\n<p>5.4.2. If there are indications of drift or deviations, adjust the calibration frequency accordingly.<\/p>\n\n\n\n<p>5.<strong>5. Maintenance and Repairs:<\/strong> <\/p>\n\n\n\n<p>5.5.1. Take into account any recent maintenance or repairs performed on the HPLC instrument. <\/p>\n\n\n\n<p>5.5.2. Instruments that underwent significant repairs may require more frequent calibration initially.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"52_Recommended_Calibration_Frequency\"><\/span>5.<strong>2. Recommended Calibration Frequency:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>5.<strong>2.1. Monthly Calibration:<\/strong> <\/p>\n\n\n\n<p>5.2.1.1. Recommended for instruments with high usage or critical applications. <\/p>\n\n\n\n<p>5.2.1.2. Ensures continuous accuracy and reliability.<\/p>\n\n\n\n<p>5.<strong>2.2. Quarterly Calibration:<\/strong> <\/p>\n\n\n\n<p>5.2.2.1. Appropriate for instruments with moderate usage and stable historical performance.<\/p>\n\n\n\n<p> 5.2.2.2. Balances the need for accuracy with operational efficiency.<\/p>\n\n\n\n<p>5.<strong>2.3. Semi-Annual Calibration:<\/strong> <\/p>\n\n\n\n<p>5.2.3.1. Suitable for instruments with low usage or consistently stable performance. <\/p>\n\n\n\n<p>5.2.3.2. Ensures compliance while minimizing disruption to routine operations.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"53_Procedure_for_Adjusting_Calibration_Frequency\"><\/span>5.<strong>3. Procedure for Adjusting Calibration Frequency:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>5.<strong>3.1. Periodic Review:<\/strong> <\/p>\n\n\n\n<p>5.3.1.1. Conduct a periodic review of calibration records and instrument performance. <\/p>\n\n\n\n<p>5.3.1.2. Assess whether any changes in usage or maintenance necessitate an adjustment in calibration frequency.<\/p>\n\n\n\n<p>5.<strong>3.2. Risk Assessment:<\/strong> <\/p>\n\n\n\n<p>5.3.2.1. Perform a risk assessment to identify potential consequences of calibration drift. <\/p>\n\n\n\n<p>5.3.2.2. Adjust calibration frequency based on the assessed level of risk.<\/p>\n\n\n\n<p>5.<strong>3.3. Documentation:<\/strong> <\/p>\n\n\n\n<p>5.3.3.1. Document any changes in calibration frequency in the laboratory&#8217;s calibration schedule. <\/p>\n\n\n\n<p>5.3.3.2. Communicate adjustments to relevant personnel and update the SOP accordingly.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"6_Calibration_Procedure\"><\/span><strong>6. Calibration Procedure:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>6.1. Preliminary Steps:<\/strong> <\/p>\n\n\n\n<p>6.1.1. Ensure the HPLC system is powered on and stabilized for at least 30 minutes. <\/p>\n\n\n\n<p>6.1.2. Verify that the mobile phase reservoirs are filled with the correct solutions. 6.1.3. Check that the column is properly installed and conditioned.<\/p>\n\n\n\n<p><strong>6.2. Instrument Verification:<\/strong> <\/p>\n\n\n\n<p>6.2.1. Perform an initial system suitability test using a standard sample. <\/p>\n\n\n\n<p>6.2.2. Verify the system parameters, including flow rate, pressure, and temperature. <\/p>\n\n\n\n<p>6.2.3. Record the initial conditions in the calibration logbook.<\/p>\n\n\n\n<p><strong>6.3. Detector Calibration:<\/strong> <\/p>\n\n\n\n<p>6.3.1. Inject a standard solution and optimize detector parameters. <\/p>\n\n\n\n<p>6.3.2. Confirm the wavelength accuracy using a certified standard. <\/p>\n\n\n\n<p>6.3.3. Record the detector settings in the logbook.<\/p>\n\n\n\n<p><strong>6.4. Flow Rate Calibration:<\/strong> <\/p>\n\n\n\n<p>6.4.1. Use a calibrated flowmeter to measure the actual flow rate. <\/p>\n\n\n\n<p>6.4.2. Adjust the flow rate settings on the instrument accordingly. <\/p>\n\n\n\n<p>6.4.3. Document the flow rate adjustments in the logbook.<\/p>\n\n\n\n<p><strong>6.5. Pressure Calibration:<\/strong> <\/p>\n\n\n\n<p>6.5.1. Connect a calibrated pressure gauge to the system. <\/p>\n\n\n\n<p>6.5.2. Compare the gauge reading with the instrument display. <\/p>\n\n\n\n<p>6.5.3. Adjust the pressure settings if necessary and record changes.<\/p>\n\n\n\n<p><strong>6.6. System Suitability Testing:<\/strong> <\/p>\n\n\n\n<p>6.6.1. Run a system suitability test using a standard mixture. <\/p>\n\n\n\n<p>6.6.2. Ensure that peak resolution and retention times meet acceptance criteria. <\/p>\n\n\n\n<p>6.6.3. Document the test results in the logbook.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"7_Documentation\"><\/span><strong>7. Documentation:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>7.<strong>1. Documentation Preparation:<\/strong><\/p>\n\n\n\n<p>7.<strong>1.1. Calibration Logbook:<\/strong> <\/p>\n\n\n\n<p>7.1.1.1. Maintain a dedicated calibration logbook for each HPLC instrument. <\/p>\n\n\n\n<p>7.1.1.2. Record instrument identification, date, and details of the calibration activities.<\/p>\n\n\n\n<p>7.<strong>1.2. Standard Operating Procedures (SOPs):<\/strong> <\/p>\n\n\n\n<p>7.1.2.1. Ensure all personnel are familiar with the relevant SOPs for calibration. <\/p>\n\n\n\n<p>7.1.2.2. Document any deviations from the SOP and the justification for such deviations.<\/p>\n\n\n\n<p>7.<strong>2. Pre-Calibration Documentation:<\/strong><\/p>\n\n\n\n<p>7.<strong>2.1. Calibration Plan:<\/strong> <\/p>\n\n\n\n<p>7.2.1.1. Develop a calibration plan specifying the instruments, standards, and equipment to be used. <\/p>\n\n\n\n<p>7.2.1.2. Include details of the calibration frequency and any specific requirements.<\/p>\n\n\n\n<p>7.<strong>2.2. Material Verification:<\/strong> <\/p>\n\n\n\n<p>7.2.2.1. Document the verification of calibration standards and reagents. <\/p>\n\n\n\n<p>7.2.2.2. Confirm the expiration dates and traceability of all materials used.<\/p>\n\n\n\n<p>7.<strong>3. Calibration Activities Documentation:<\/strong><\/p>\n\n\n\n<p>7.<strong>3.1. Initial System Checks:<\/strong> <\/p>\n\n\n\n<p>7.3.1.1. Record the results of the initial system checks performed by the analyst. <\/p>\n\n\n\n<p>7.3.1.2. Document any observations, abnormalities, or adjustments made.<\/p>\n\n\n\n<p>7.<strong>3.2. Instrument Verification:<\/strong> <\/p>\n\n\n\n<p>7.3.2.1. Document the parameters verified during the system suitability test. <\/p>\n\n\n\n<p>7.3.2.2. Record any deviations and corrective actions taken.<\/p>\n\n\n\n<p>7.<strong>3.3. Detector Calibration:<\/strong> <\/p>\n\n\n\n<p>7.3.3.1. Record detector calibration parameters and adjustments made.<\/p>\n\n\n\n<p> 7.3.3.2. Include details of the standard solution used for calibration.<\/p>\n\n\n\n<p>7.<strong>3.4. Flow Rate Calibration:<\/strong> <\/p>\n\n\n\n<p>7.3.4.1. Document the flow rate measurements using a calibrated flowmeter. <\/p>\n\n\n\n<p>7.3.4.2. Record any adjustments made to achieve the desired flow rate.<\/p>\n\n\n\n<p>7.<strong>4.5. Pressure Calibration:<\/strong> <\/p>\n\n\n\n<p>7.4.5.1. Document the results of pressure calibration using a calibrated gauge. <\/p>\n\n\n\n<p>7.4.5.2. Record any adjustments made to meet specified pressure requirements.<\/p>\n\n\n\n<p>7.<strong>5.6. System Suitability Testing:<\/strong> <\/p>\n\n\n\n<p>7.5.6.1. Record the results of the system suitability test. <\/p>\n\n\n\n<p>7.5.6.2. Include details of peak resolution, retention times, and other relevant parameters.<\/p>\n\n\n\n<p>7.<strong>4. Post-Calibration Documentation:<\/strong><\/p>\n\n\n\n<p>7.<strong>4.1. Review and Approval:<\/strong> <\/p>\n\n\n\n<p>7.4.1.1. Ensure that the calibration logbook is reviewed by the Laboratory Manager. <\/p>\n\n\n\n<p>7.4.1.2. Obtain necessary approvals and signatures to confirm completion.<\/p>\n\n\n\n<p>7.<strong>4.2. Deviation Reports:<\/strong> <\/p>\n\n\n\n<p>7.4.2.1. If deviations occurred, prepare a deviation report. <\/p>\n\n\n\n<p>7.4.2.2. Include details of the deviation, its impact, and corrective actions taken.<\/p>\n\n\n\n<p>7.<strong>5. Record Retention:<\/strong> <\/p>\n\n\n\n<p>7.5.1. Maintain calibration records for a specified retention period as per regulatory requirements. <\/p>\n\n\n\n<p>7.5.2. Store records in a secure and accessible location.<\/p>\n\n\n\n<p>7.<strong>6. Training:<\/strong> <\/p>\n\n\n\n<p>7.6.1. Ensure all personnel involved in calibration activities are trained on proper documentation procedures. <\/p>\n\n\n\n<p>7.6.2. Periodically review and update training programs.<\/p>\n\n\n\n<p>7.<strong>7. Review:<\/strong> <\/p>\n\n\n\n<p>7.7.1. Periodically review this SOP to ensure alignment with industry standards and regulatory requirements. <\/p>\n\n\n\n<p>7.7.2. Update the documentation process as needed based on new information or changes in laboratory procedures.<\/p>\n\n\n\n<p>7.<strong>8. Approval:<\/strong> <\/p>\n\n\n\n<p>7.8.1. This SOP is approved by the Laboratory Manager. <\/p>\n\n\n\n<p>7.8.2. Review and approval shall be documented in the SOP.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"8_Training\"><\/span><strong>8. Training:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>8.1. Ensure that all personnel involved in HPLC calibration are adequately trained. <\/p>\n\n\n\n<p>8.2. Periodically review and update training programs.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"9_References\"><\/span><strong>9. References:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p> 9.1. Manufacturer&#8217;s manual for the specific HPLC instrument. <\/p>\n\n\n\n<p>9.2. Relevant industry standards and regulations.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"10_Review\"><\/span><strong>10. Review:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>10.1. Periodically review and update this SOP as needed. <\/p>\n\n\n\n<p>10.2. Conduct internal audits to ensure compliance.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"11_Approval\"><\/span><strong>11. Approval:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>11.1. This SOP is approved by the Laboratory Manager. <\/p>\n\n\n\n<p>11.2. Review and approval shall be documented in the SOP.<\/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&nbsp;<a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/jobs\/\">jobs<\/a>, follow us on<strong>&nbsp;<a href=\"https:\/\/www.linkedin.com\/company\/pharmaceuticalcarrier\/?viewAsMember=true\" target=\"_blank\" rel=\"noreferrer noopener\">LinkedIn<\/a><\/strong><\/p>\n\n\n\n<p><strong>For Editable SOPs in Word format\u00a0<a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/contact\/\">contact us<\/a>\u00a0on\u00a0<a href=\"mailto:info@pharmaceuticalcarrier.com\">info@pharmaceuticalcarrier.com<\/a><\/strong><\/p>\n\n\n\n<p>For more information kindly follow us on <a href=\"http:\/\/pharmaguidelines.co.uk\">pharmaguidelines.co.uk<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>1. Purpose: 1.1 To ensure the accuracy and reliability of High-Performance Liquid Chromatography (HPLC) results. 1.2. To maintain compliance with regulatory requirements. 2. Scope: 2.1. Applicable to all HPLC instruments in the laboratory. 2.2. Covers calibration procedures for low-pressure quaternary<\/p>\n<p><a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/02\/26\/standard-operating-procedure-sop-for-calibration-of-hplc-high-performance-liquid-chromatograph-2\/\" class=\"blog-read-more\">Read More<\/a><\/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":[156,165],"tags":[1637,465,270,1626,421,1631,1013,729,1636,677,1632,1633,256,166,167,1635,304],"class_list":["post-7089","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-industry","category-standard-operating-procedure","tag-analyst-responsibilities","tag-calibration","tag-compliance","tag-detector-calibration","tag-documentation","tag-flow-rate-calibration","tag-high-performance-liquid-chromatograph","tag-hplc","tag-instrument-verification","tag-laboratory-procedures","tag-low-pressure-quaternary-gradient","tag-pressure-calibration","tag-quality-assurance","tag-sop","tag-standard-operating-procedure","tag-system-suitability-testing","tag-training"],"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":6,"uagb_excerpt":"1. Purpose: 1.1 To ensure the accuracy and reliability of High-Performance Liquid Chromatography (HPLC) results. 1.2. To maintain compliance with regulatory requirements. 2. Scope: 2.1. Applicable to all HPLC instruments in the laboratory. 2.2. Covers calibration procedures for low-pressure quaternaryRead More","amp_enabled":true,"_links":{"self":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/7089","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=7089"}],"version-history":[{"count":3,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/7089\/revisions"}],"predecessor-version":[{"id":7341,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/7089\/revisions\/7341"}],"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=7089"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/categories?post=7089"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/tags?post=7089"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}