{"id":7103,"date":"2024-03-01T18:31:07","date_gmt":"2024-03-01T13:01:07","guid":{"rendered":"https:\/\/pharmaceuticalcarrier.com\/?p=7103"},"modified":"2024-04-11T15:46:16","modified_gmt":"2024-04-11T10:16:16","slug":"standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus","status":"publish","type":"post","link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/","title":{"rendered":"Standard Operating Procedure (SOP) for Operational Check of Disintegration Test Apparatus"},"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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#10_Purpose\" >1.0 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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#20_Scope\" >2.0 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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#30_Responsibilities\" >3.0 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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#31_Quality_Control_QC_Personnel\" >3.1 Quality Control (QC) Personnel<\/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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#32_Laboratory_supervisor\" >3.2 Laboratory supervisor<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#33_Maintenance_personnel\" >3.3 Maintenance personnel<\/a><\/li><\/ul><\/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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#40_Equipment_and_Materials\" >4.0 Equipment and Materials:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#50_Procedure\" >5.0 Procedure:<\/a><\/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\/2024\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#60_Documentation\" >6.0 Documentation:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2024\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#70_Training\" >7.0 Training:<\/a><\/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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#80_References\" >8.0 References:<\/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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#90_Revision_History\" >9.0 Revision History:<\/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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#100_Approval\" >10.0 Approval:<\/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\/03\/01\/standard-operating-procedure-sop-for-operational-check-of-disintegration-test-apparatus\/#110_Distribution\" >11.0 Distribution:<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"10_Purpose\"><\/span><strong>1.0 Purpose:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To ensure the proper functioning and accuracy of the Disintegration Test Apparatus in accordance with regulatory standards.<\/p><div class=\"pharm-content\" id=\"pharm-3551282604\"><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=\"20_Scope\"><\/span><strong>2.0 Scope:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>This SOP applies to all personnel involved in the operation and maintenance of the Disintegration Test Apparatus.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"30_Responsibilities\"><\/span><strong>3.0 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_Quality_Control_QC_Personnel\"><\/span>3.1 Quality Control (QC) Personnel<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Responsibilities:<\/strong><\/p>\n\n\n\n<p><strong>3.1 Pre-Check Preparation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.1.1 QC personnel are responsible for ensuring that the Disintegration Test Apparatus is clean and free from any residues from previous tests.<\/li>\n\n\n\n<li>3.1.2 Verify the calibration status of the apparatus and check the calibration certificate.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.2 Start-up Procedure:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.2.1 Initiate the warming up of the apparatus for a minimum of 30 minutes.<\/li>\n\n\n\n<li>3.2.2 Verify the proper functioning of the temperature control system.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.3 Mechanical Checks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.3.1 Inspect the condition of the disintegration test baskets, reporting any defects or damage.<\/li>\n\n\n\n<li>3.3.2 Evaluate the motorized drive for smooth operation, identifying and reporting any unusual noise.<\/li>\n\n\n\n<li>3.3.3 Confirm the lifting mechanism&#8217;s functionality, ensuring even lifting of the baskets.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.4 Operational Check:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.4.1 Place disintegration test discs in each basket according to standard specifications.<\/li>\n\n\n\n<li>3.4.2 Fill the dissolution medium as specified in the test procedure.<\/li>\n\n\n\n<li>3.4.3 Set the stopwatch timer to the predetermined disintegration time.<\/li>\n\n\n\n<li>3.4.4 Observe the test discs continuously and record the time of disintegration.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.5 Post-Operational Checks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.5.1 Verify that the disintegration test meets the specified time limit.<\/li>\n\n\n\n<li>3.5.2 Record any deviations from the standard procedure and report them to the laboratory supervisor.<\/li>\n\n\n\n<li>3.5.3 Collaborate with maintenance personnel to address identified issues.<\/li>\n<\/ul>\n\n\n\n<p><strong>4.0 Documentation:<\/strong> <\/p>\n\n\n\n<p>QC personnel are responsible for accurately documenting all observations, deviations, and corrective actions in the Disintegration Test Apparatus Logbook.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"32_Laboratory_supervisor\"><\/span>3.2 Laboratory supervisor <span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Responsibilities:<\/strong><\/p>\n\n\n\n<p><strong>3.1 Pre-Check Preparation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.1.1 Verify that QC personnel have ensured the cleanliness of the Disintegration Test Apparatus and validated the calibration status.<\/li>\n\n\n\n<li>3.1.2 Confirm that all required materials and equipment are available for the operational check.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.2 Start-up Procedure:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.2.1 Supervise the initiation of the warming-up process, ensuring it aligns with the recommended duration.<\/li>\n\n\n\n<li>3.2.2 Confirm the proper functioning of the temperature control system.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.3 Mechanical Checks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.3.1 Review the inspection reports on the condition of disintegration test baskets, motorized drive, and lifting mechanism.<\/li>\n\n\n\n<li>3.3.2 Address any reported defects, damages, or irregularities in collaboration with QC personnel.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.4 Operational Check:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.4.1 Oversee the placement of disintegration test discs in each basket, verifying compliance with standard specifications.<\/li>\n\n\n\n<li>3.4.2 Monitor the filling of the dissolution medium as per the specified test procedure.<\/li>\n\n\n\n<li>3.4.3 Ensure the stopwatch timer is set correctly, and the operational check is initiated per the predetermined disintegration time.<\/li>\n\n\n\n<li>3.4.4 Review continuous observations of the test discs, providing guidance if needed.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.5 Post-Operational Checks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.5.1 Validate that the disintegration test meets the specified time limit.<\/li>\n\n\n\n<li>3.5.2 Review QC personnel&#8217;s documentation of any deviations and collaborate with them to address issues.<\/li>\n\n\n\n<li>3.5.3 Coordinate with maintenance personnel for necessary repairs or adjustments.<\/li>\n<\/ul>\n\n\n\n<p><strong>4.0 Documentation:<\/strong> <\/p>\n\n\n\n<p>Supervise the accurate documentation of all observations, deviations, and corrective actions in the Disintegration Test Apparatus Logbook.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"33_Maintenance_personnel\"><\/span>3.3 Maintenance personnel <span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong>Responsibilities:<\/strong><\/p>\n\n\n\n<p><strong>3.1 Pre-Check Preparation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.1.1 Collaborate with QC and Laboratory Supervisor to review any reported defects or issues from previous tests.<\/li>\n\n\n\n<li>3.1.2 Ensure availability of necessary tools and spare parts for potential repairs.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.2 Start-up Procedure:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.2.1 Check the power supply and electrical connections to ensure stability.<\/li>\n\n\n\n<li>3.2.2 Verify the proper functioning of the apparatus during the warm-up phase.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.3 Mechanical Checks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.3.1 Conduct a thorough inspection of the disintegration test baskets, motorized drive, and lifting mechanism.<\/li>\n\n\n\n<li>3.3.2 Address any identified defects or irregularities promptly and report them to the Laboratory Supervisor.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.4 Operational Check:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.4.1 Monitor the operational check process for any signs of malfunction or unusual noise.<\/li>\n\n\n\n<li>3.4.2 Collaborate with QC personnel and the Laboratory Supervisor to troubleshoot and rectify issues during the test.<\/li>\n<\/ul>\n\n\n\n<p><strong>3.5 Post-Operational Checks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>3.5.1 Collaborate with QC personnel to review documentation of deviations and issues.<\/li>\n\n\n\n<li>3.5.2 Schedule and perform routine maintenance based on operational check findings.<\/li>\n\n\n\n<li>3.5.3 Ensure that the Disintegration Test Apparatus is left in a clean and operational state after use.<\/li>\n<\/ul>\n\n\n\n<p><strong>4.0 Documentation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>4.1 Document all maintenance activities, including repairs and adjustments made during the operational check.<\/li>\n\n\n\n<li>4.2 Maintain a record of spare parts used and their stock levels.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"40_Equipment_and_Materials\"><\/span><strong>4.0 Equipment and Materials:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>4.1 Disintegration Test Apparatus<\/li>\n\n\n\n<li>4.2 Stopwatch<\/li>\n\n\n\n<li>4.3 Calibration weights (if applicable)<\/li>\n\n\n\n<li>4.4 Manufacturer&#8217;s manual<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"50_Procedure\"><\/span><strong>5.0 Procedure:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>5.1 Pre-Check Preparation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>5.1.1 Ensure that the Disintegration Test Apparatus is clean and free from any residues from previous tests.<\/li>\n\n\n\n<li>5.1.2 Check the electrical connections and ensure that the power supply is stable.<\/li>\n\n\n\n<li>5.1.3 Verify that the apparatus is properly calibrated (if applicable) by checking the calibration certificate.<\/li>\n<\/ul>\n\n\n\n<p><strong>5.2 Start-up Procedure:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>5.2.1 Turn on the power switch and allow the apparatus to warm up for a minimum of 30 minutes.<\/li>\n\n\n\n<li>5.2.2 Check that the temperature control system is functioning properly.<\/li>\n<\/ul>\n\n\n\n<p><strong>5.3 Mechanical Checks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>5.3.1 Inspect the condition of the disintegration test baskets, ensuring there are no defects or damage.<\/li>\n\n\n\n<li>5.3.2 Check that the motorized drive is operating smoothly without any unusual noise.<\/li>\n\n\n\n<li>5.3.3 Verify that the lifting mechanism is functioning correctly and lifting the baskets evenly.<\/li>\n<\/ul>\n\n\n\n<p><strong>5.4 Operational Check:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>5.4.1 Place disintegration test discs in each basket as per standard specifications.<\/li>\n\n\n\n<li>5.4.2 Fill the dissolution medium as specified in the test procedure.<\/li>\n\n\n\n<li>5.4.3 Set the timer on the stopwatch to the predetermined disintegration time.<\/li>\n\n\n\n<li>5.4.4 Start the apparatus and initiate the disintegration test.<\/li>\n\n\n\n<li>5.4.5 Observe the test discs continuously and record the time at which disintegration occurs.<\/li>\n<\/ul>\n\n\n\n<p><strong>5.5 Post-Operational Checks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>5.5.1 Ensure that the disintegration test meets the specified time limit.<\/li>\n\n\n\n<li>5.5.2 Record any deviations from the standard procedure and report them to the supervisor.<\/li>\n\n\n\n<li>5.5.3 Turn off the power switch and clean the apparatus thoroughly after use.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"60_Documentation\"><\/span><strong>6.0 Documentation:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>6.1 Documentation Requirements:<\/strong><\/p>\n\n\n\n<p><strong>6.1.1 Pre-Check Documentation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>QC personnel must document the cleanliness verification of the Disintegration Test Apparatus.<\/li>\n\n\n\n<li>Record the calibration status and check for the calibration certificate.<\/li>\n<\/ul>\n\n\n\n<p><strong>6.1.2 Start-up Procedure Documentation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Document the initiation of the warming-up process, including the start time and duration.<\/li>\n\n\n\n<li>Record the verification of the temperature control system&#8217;s proper functioning.<\/li>\n<\/ul>\n\n\n\n<p>6.1<strong>.3 Mechanical Checks Documentation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Maintain inspection reports on the condition of disintegration test baskets, motorized drive, and lifting mechanism.<\/li>\n\n\n\n<li>Document any defects, damages, or irregularities reported by QC personnel.<\/li>\n<\/ul>\n\n\n\n<p><strong>6.1.4 Operational Check Documentation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Record the placement of disintegration test discs in each basket, ensuring compliance with standard specifications.<\/li>\n\n\n\n<li>Document the filling of the dissolution medium according to the specified test procedure.<\/li>\n\n\n\n<li>Note the stopwatch timer settings and record the time of disintegration.<\/li>\n<\/ul>\n\n\n\n<p><strong>6.1.5 Post-Operational Checks Documentation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Document the validation of disintegration test results meeting the specified time limit.<\/li>\n\n\n\n<li>Record any deviations reported by QC personnel and collaborative efforts to address them.<\/li>\n\n\n\n<li>Document maintenance activities, repairs, or adjustments made during or after the operational check.<\/li>\n<\/ul>\n\n\n\n<p><strong>6.2 Record Keeping:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Maintain a Disintegration Test Apparatus Logbook for centralized documentation.<\/li>\n\n\n\n<li>Include details such as date, time, personnel involved, and any observed deviations.<\/li>\n<\/ul>\n\n\n\n<p><strong>6.3 Training Records:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Document the training records of personnel involved in the operational check procedures.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"70_Training\"><\/span><strong>7.0 Training:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>All personnel involved in the operational check must undergo proper training on the use and maintenance of the Disintegration Test Apparatus.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"80_References\"><\/span><strong>8.0 References:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Refer to the manufacturer&#8217;s manual for specific instructions and guidelines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"90_Revision_History\"><\/span><strong>9.0 Revision History:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Document any changes or updates made to this SOP.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"100_Approval\"><\/span><strong>10.0 Approval:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>This SOP is to be reviewed and approved by the Quality Assurance department.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"110_Distribution\"><\/span><strong>11.0 Distribution:<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Distribute this SOP to all relevant personnel and ensure they are aware of and trained on its contents.<\/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>&nbsp;<\/p>\n\n\n\n<p><strong>For Editable SOPs in word format&nbsp;<a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/contact\/\">contact us<\/a>&nbsp;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\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-a6356b19-2127-4ff3-920d-37d8e45505f1\" href=\"https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Blank-SOP-template-3.docx\">Blank-SOP-template-3<\/a><a href=\"https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Blank-SOP-template-3.docx\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-a6356b19-2127-4ff3-920d-37d8e45505f1\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Ensure the reliability and precision of your pharmaceutical testing processes with our meticulously crafted Standard Operating Procedure (SOP) for the Operational Check of Disintegration Test Apparatus. This comprehensive guide outlines the step-by-step procedure, from pre-check preparation to post-operational checks, ensuring that your Disintegration Test Apparatus functions seamlessly and meets regulatory standards. Trust our SOP to empower your laboratory personnel with the knowledge and procedures necessary to maintain the accuracy and efficiency of your disintegration testing, promoting quality control and 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":[156,165],"tags":[270,1652,677,1653,1530,257,166],"class_list":["post-7103","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-industry","category-standard-operating-procedure","tag-compliance","tag-disintegration-test","tag-laboratory-procedures","tag-operational-check","tag-pharmaceutical-testing","tag-quality-control","tag-sop"],"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":9,"uagb_excerpt":"Ensure the reliability and precision of your pharmaceutical testing processes with our meticulously crafted Standard Operating Procedure (SOP) for the Operational Check of Disintegration Test Apparatus. This comprehensive guide outlines the step-by-step procedure, from pre-check preparation to post-operational checks, ensuring that your Disintegration Test Apparatus functions seamlessly and meets regulatory standards. Trust our SOP to&hellip;","amp_enabled":true,"_links":{"self":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/7103","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=7103"}],"version-history":[{"count":4,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/7103\/revisions"}],"predecessor-version":[{"id":7346,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/7103\/revisions\/7346"}],"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=7103"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/categories?post=7103"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/tags?post=7103"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}