{"id":606,"date":"2025-04-23T07:55:11","date_gmt":"2025-04-23T07:55:11","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=606"},"modified":"2025-04-23T07:55:11","modified_gmt":"2025-04-23T07:55:11","slug":"sop-title-validation-of-analysts-in-quality-control-department","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=606","title":{"rendered":"SOP Title: Validation of Analysts in Quality Control Department"},"content":{"rendered":"

SOP Title:<\/u><\/strong> Validation of Analysts in Quality Control Department\u00a0 <\/u><\/strong><\/p>\n

    \n
  1. Objective:<\/strong><\/li>\n<\/ol>\n

    To lay down the procedure for Validation of Analysts in Quality Control Department.<\/p>\n

     <\/p>\n

      \n
    1. Scope:<\/strong><\/li>\n<\/ol>\n

      This SOP is applicable for Validation of Analysts in Quality Control Department.<\/p>\n

       <\/p>\n

        \n
      1. Responsibility:<\/strong><\/li>\n<\/ol>\n
          \n
        • Quality Control: To prepare and review the SOP. To follow the procedures laid down for Validation of Analysts in Quality Control Department as per this SOP.<\/li>\n
        • Quality Assurance Department: To review and approve the SOP and Annexures.<\/li>\n<\/ul>\n

          \u00a0<\/strong><\/p>\n

            \n
          1. Accountability:<\/strong><\/li>\n<\/ol>\n

            Head Quality Control Department, Head Quality Assurance Department<\/p>\n

             <\/p>\n

              \n
            1. Procedure:<\/strong><\/li>\n<\/ol>\n\n\n\n\n\n\n\n\n\n\n
              5.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/strong><\/td>\nValidation of Analysts:<\/strong><\/td>\n<\/tr>\n
              5.1.1<\/td>\nNew appointed analyst should go through all the relevant SOP training before starting actual job.<\/td>\n <\/td>\n<\/tr>\n
              5.1.2<\/td>\nAfter completion of SOP training, Analyst should complete analyst Validation for Complex and Non-complex tests before performing routine testing.<\/td>\n <\/td>\n<\/tr>\n
              5.1.3<\/td>\nSupervisor\/Group leader shall allocate approved or routine sample to the analyst for analyst validation based on type of test i.e. Complex test or Non-complex test.<\/td>\n <\/td>\n<\/tr>\n
              5.1.4<\/td>\nIn case of Complex test, approved \/already tested sample shall be given for analyst validation.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.5<\/td>\nIn case of Non-complex test, routine \/under test or approved sample shall be given for analyst validation.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.6<\/td>\nFor distinguishing of Complex and Non-complex test refer below table but not limited to;<\/td>\n <\/td>\n<\/tr>\n
              Complex Test:<\/strong><\/p>\n\n\n\n\n\n\n
              Assay by HPLC\/UV\/GC\/AAS<\/td>\nWater Content<\/td>\n<\/tr>\n
              Dissolution by HPLC\/UV\/ AAS<\/td>\nWater analysis- Microbiology<\/td>\n<\/tr>\n
              Uniformity of Content \u00a0by HPLC\/UV\/AAS<\/td>\nEnvironmental Monitoring<\/td>\n<\/tr>\n
              Related Substances \u00a0HPLC\/UV\/GC<\/td>\nSerial culture dilution<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

               <\/p>\n\n\n\n\n
              <\/td>\n<\/td>\n<\/td>\n<\/tr>\n
              Non-complex Test:<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
              Description<\/td>\nLoss on Drying<\/td>\n*Calcium\/ Fluorides\/ Chlorides<\/td>\n<\/tr>\n
              Solubility<\/td>\n#<\/strong>Acetyl Value<\/td>\n*Phosphates\/ Potassium<\/td>\n<\/tr>\n
              \u25cf Clarity of Solutions<\/td>\n#<\/strong>Acid Value\u00a0 & Este<\/p>\n

              Value<\/td>\n

              		*Sulphates\/ Nitrates<\/td>\n<\/tr>\n
              \u25cf Colour of Solutions<\/td>\n#<\/strong>Hydroxyl Value<\/td>\n*Oxidising substances<\/td>\n<\/tr>\n
              Melting Point\/ Boiling Point<\/td>\n#<\/strong>Peroxide Value<\/td>\nUniformity of weight<\/td>\n<\/tr>\n
              pH<\/td>\n#<\/strong>Saponification Value<\/td>\nPhysical parameters<\/td>\n<\/tr>\n
              Freezing Point<\/td>\n#<\/strong>Iodine Value<\/td>\nHardness Test<\/td>\n<\/tr>\n
              Dis<\/p>\n

              illation Range<\/td>\n

              		Volumetric titrations<\/td>\nFriability Test<\/td>\n<\/tr>\n
              Optical Rotation<\/td>\nBulk density\/Tapped density<\/td>\nDisintegration Test<\/td>\n<\/tr>\n
              Weight per ml \/ Relative density<\/td>\nRefractive Index<\/td>\nBursting strength<\/td>\n<\/tr>\n
              Conductivity<\/td>\nSulphated Ash\/Loss on Ignition<\/td>\nGrammage of packing materials<\/td>\n<\/tr>\n
              Viscosity<\/td>\nThin layer chromatography<\/td>\nThickness of Packing Materials<\/td>\n<\/tr>\n
              Powder Fineness<\/td>\nArsenic<\/td>\nGrowth Promotion Test<\/td>\n<\/tr>\n
              \u25baResidue on evaporation<\/td>\nHeavy Metals<\/td>\nIdentification of cultures<\/td>\n<\/tr>\n
              \u25baTotal dissolved solids<\/td>\n*Acidity\/Alkalinity<\/td>\nTest for pathogens<\/td>\n<\/tr>\n
              Total Organic Carbon<\/td>\n*Aluminium \/Ammonium<\/td>\n <\/td>\n<\/tr>\n
              Sulphur Dioxide<\/td>\n*Iron \/ Lead\/ Magnesium<\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n
              5.1.7<\/td>\nNote: <\/strong><\/p>\n

              \u00a0\u00a0 \u25cf\u00a0\u00a0\u00a0 <\/strong>If the analyst is qualified for any one of the test above marked then the analyst can be considered qualified for rest of the tests of same marked.<\/td>\n

              		 <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

               <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
              <\/td>\n<\/td>\n<\/td>\n<\/tr>\n
              5.1.8<\/td>\n\u25ba If the analyst is qualified for any one of the test above marked then the analyst can be considered qualified for rest of the tests of same marked.<\/td>\n <\/td>\n<\/tr>\n
              5.1.9<\/td>\n#\u00a0\u00a0 <\/strong>If the analyst is qualified for any one of the test above marked then the analyst can be considered qualified for rest of the tests of same marked.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.10<\/td>\n*\u00a0\u00a0 If the analyst is qualified for Heavy Metal or Arsenic any one of the test then the analyst can be considered qualified for the tests above marked.<\/td>\n <\/td>\n<\/tr>\n
              5.1.11<\/td>\nFor complex test, analyst shall give the request for AWR pages to QA Department as per test before initiating the testing.<\/td>\n <\/td>\n<\/tr>\n
              5.1.12<\/td>\nFor issuance of AWR refer SOP \u201cControl of Documents, Preparation, Approval, Issuance and Maintenance.<\/td>\n <\/td>\n<\/tr>\n
              5.1.13<\/td>\nAfter getting AWR from Quality Assurance, new analyst shall initiate the testing with online documentation under the observation of trained analyst.<\/td>\n <\/td>\n<\/tr>\n
              5.1.14<\/td>\nFor Non-complex test, analyst can report all the preparation and results directly on regular AWR sheet issued by Quality Assurance Department.<\/td>\n <\/td>\n<\/tr>\n
              5.1.15<\/td>\nAnalyst shall fill required details in \u201cAnalyst Validation and Evaluation Record\u201d concurrently as per Annexure.<\/td>\n <\/td>\n<\/tr>\n
              5.1.16<\/td>\nIf routine\/under test sample results found out of specification limit then initiate investigation as per OOS SOP.<\/td>\n <\/td>\n<\/tr>\n
              5.1.17<\/td>\nTrainer shall monitor new analyst during testing and write observations in analyst validation and evaluation record.<\/td>\n <\/td>\n<\/tr>\n
              5.1.18<\/td>\nTrainer\/Group leader has to write conclusion, whether analyst shall be qualified or not qualified based on results obtained and acceptance criteria.<\/td>\n <\/td>\n<\/tr>\n
              5.1.19<\/td>\nIf new analyst fails to meet acceptance criteria of analyst validation, then Trainer\/Supervisor shall investigate the cause of failure and recommend for analyst revalidation with re-training.<\/td>\n <\/td>\n<\/tr>\n
              5.1.20<\/td>\nAnalyst should follow Standard Test Procedure and specification during testing.<\/td>\n <\/td>\n<\/tr>\n
              5.1.22<\/td>\nAcceptance criteria for standard replicate injections shall remain same as defined in standard test procedure.<\/td>\n <\/td>\n<\/tr>\n
              5.1.23<\/td>\nIf New analyst qualified for Assay By HPLC then analyst shall be considered qualified for Assay by UV\/AAS\/GC. Same criteria are applicable for rest of the tests.<\/td>\n <\/td>\n<\/tr>\n
              5.1.24<\/td>\nAnalyst should fill the \u2018Analyst Validation Log Sheet\u2019 after completion of validation records and certification as per Annexure.<\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

              \u00a0<\/strong><\/p>\n

                \n
              1. Definitions \/ Abbreviations<\/strong>:<\/strong><\/li>\n<\/ol>\n
                  \n
                • Definitions :<\/strong><\/li>\n
                • Abbreviations :<\/strong><\/li>\n<\/ul>\n\n\n\n\n\n\n\n\n\n\n
                  Abbreviation<\/strong><\/td>\nExpansion<\/strong><\/td>\n<\/tr>\n
                  No.<\/td>\nNumber<\/td>\n<\/tr>\n
                  AWR<\/td>\nAnalytical Work Record<\/td>\n<\/tr>\n
                  HPLC<\/td>\nHigh Performance Liquid Chromatography<\/td>\n<\/tr>\n
                  GC<\/td>\nGas Chromatography<\/td>\n<\/tr>\n
                  AAS<\/td>\nAtomic Absorption Spectroscopy<\/td>\n<\/tr>\n
                  OOS<\/td>\nOut of Specification<\/td>\n<\/tr>\n
                  UV<\/td>\nUltra Violet<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                   <\/p>\n

                  *Note – Ready to use SOP available in \u201cDOWNLOAD\u201d Section.<\/u><\/em><\/strong><\/p>\n

                   <\/p>\n","protected":false},"excerpt":{"rendered":"

                  SOP Title: Validation of Analysts in Quality Control Department\u00a0 Objective: To lay down the procedure for Validation of Analysts in Quality Control Department.   Scope: This SOP is applicable for Validation of Analysts in Quality Control Department.   Responsibility: Quality Control: To prepare and review the SOP. To follow the procedures laid down for Validation […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"templates\/template-full-width.php","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-606","post","type-post","status-publish","format-standard","hentry","category-qc-sop"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/606","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=606"}],"version-history":[{"count":1,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/606\/revisions"}],"predecessor-version":[{"id":607,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/606\/revisions\/607"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=606"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=606"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=606"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}