{"id":628,"date":"2025-04-23T10:35:21","date_gmt":"2025-04-23T10:35:21","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=628"},"modified":"2025-04-23T10:35:21","modified_gmt":"2025-04-23T10:35:21","slug":"sop-title-allotment-of-job-responsibilities-in-quality-control-department","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=628","title":{"rendered":"SOP Title: Allotment of Job Responsibilities in Quality Control Department"},"content":{"rendered":"

SOP Title:<\/u><\/strong> Allotment of Job Responsibilities in Quality Control Department<\/u><\/strong><\/p>\n

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

    To lay down the procedure for Allotment of Job Responsibilities in Quality Control Department.<\/p>\n

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

      This procedure is applicable for Allotment of Job Responsibilities of Analyst, Executive, Supervisor, and Manager in Quality Control Department.<\/p>\n

        \n
      1. Responsibility: <\/strong><\/li>\n<\/ol>\n
          \n
        • Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Allotment of Job Responsibilities 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
            \n
          1. Accountability:<\/strong><\/li>\n<\/ol>\n

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

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

              \u00a0<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
              Sr. No.<\/strong><\/td>\nProcedure<\/strong><\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              \u00a0\u00a0\u00a0\u00a0 5.1<\/strong><\/td>\nGeneral Responsibilities:- All Quality Control Staff<\/strong><\/td>\n<\/tr>\n
              5.1.1<\/td>\nKeep Laboratory neat and clean.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.2<\/td>\nCareful usage of organisation resources without any wastage.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.3<\/td>\nTo identify hazards and safety issues in Laboratory and inform Head of the Department.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.4<\/td>\nKeep good and healthy working culture in the Laboratory.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.5<\/td>\nKeep all the documents\/materials at respective places after use.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.6<\/td>\nSwitch off lights and instruments whenever not required.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.7<\/td>\nMinimise wastage of papers.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.8<\/td>\nMaintain Good Laboratory Practices in Laboratory.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.9<\/td>\nAlways think about environment hazards before generating waste.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.10<\/td>\nDo not perform any job without proper training.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.11<\/td>\nRead the Instrument\/Equipment SOP\u2019s and Standard Testing Procedures carefully before starting the analysis.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              \u00a0\u00a0\u00a0\u00a0\u00a0 5.2<\/strong><\/td>\nResponsibilities of Quality Control Head\/ Quality Control Manager:<\/strong><\/td>\n<\/tr>\n
              5.2.1<\/td>\nQuality Control Head\/ Manager is responsible for the overall monitoring of the Department.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.2<\/td>\nMaintaining Good Laboratory Practices.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.3<\/td>\nTaking care of trouble shooting during day to day analysis.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.4<\/td>\nMaintaining good rapport with all other Departments and outside parties.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.5<\/td>\nKeeping control on new product analysis and development.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.6<\/td>\nDiscussion of quality problem, if any with higher managements.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.7<\/td>\nEvaluation of stability data.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.8<\/td>\nMonitoring and evaluation of validation samples and data.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.9<\/td>\nPreparation and updating of SOP\u2019s as per requirement and current guidelines.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.10<\/td>\nInvestigation of OOS\/Incidents\/Deviations.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.11<\/td>\nConducting trainings to quality control staff.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.12<\/td>\nImpact evaluation of OOS\/Incidents\/Deviations.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.13<\/td>\nEnsuring readiness\u00a0 for non-regulatory, regulatory and internal audits all the time.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.14<\/td>\nRelease and Approval of Raw Material\/Packing Material\/Finished Product\/In process Sample reports and COA on time.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.15<\/td>\nImpact evaluation of change control.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.16<\/td>\nTo identify new manpower requirement.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.17<\/td>\nTo identify new Instrument\/Equipment requirement.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.18<\/td>\nTo ensure safety of Quality Control staff in the Department.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.19<\/td>\nTo monitor and evaluate performance of Quality Control staff.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.20<\/td>\nAny other responsibility assigned by the management as situation demand.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.21<\/td>\nTo maintain training records up to date.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              \u00a0\u00a0\u00a0\u00a0 5.3<\/strong><\/td>\nResponsibilities of Supervisor\/Group Leader\/Executive\/Assistant Manager:<\/strong><\/td>\n<\/tr>\n
              5.3.1<\/td>\nMaintaining Good Laboratory Practices.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.2<\/td>\nTaking care of trouble shooting during day to day analysis.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.3<\/td>\nDiscussion of quality problem, if any with higher managements.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.4<\/td>\nEvaluation of stability data.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.5<\/td>\nMonitoring and evaluation of validation samples and data.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.6<\/td>\nPreparation and updating of SOP\u2019s as per requirement and current guidelines.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.7<\/td>\nReview of analytical reports of Raw Material\/Packing Material\/ In process Sample \/ Finished Product and Microbiology reports.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.8<\/td>\nReview of Instrument\/Equipment usage log books.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.9<\/td>\nDaily work planning to the analysts.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.10<\/td>\nReview of new documents like Standard Testing Procedures, Specifications, Protocols etc.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.11<\/td>\nChecking of all GMP records in the Laboratory.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.12<\/td>\nInitiation of change control.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.13<\/td>\nMonitoring safety in Quality Control Department.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.14<\/td>\nChecking calibration reports and preventive maintenance records.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.15<\/td>\nConducting trainings to Quality Control staff.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.16<\/td>\nTo verify training records of Quality Control staff.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.17<\/td>\nTo maintain training records up to date.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.18<\/td>\nUpdation of sample inward records for Raw Material\/Packing Material\/Finished Product\/In process Sample\/Stability samples.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.19<\/td>\nPreparation and monitoring of Calibration\/AMC schedule in Laboratory.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.20<\/td>\nInvestigation of OOS\/Incidents\/Deviations.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.21<\/td>\nMaintaining all time readiness for non-regulatory, regulatory and internal audits.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.22<\/td>\nTo ensure safety of Quality Control staff in the Department.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.23<\/td>\nAny other responsibility assigned by the management as situation demand.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.24<\/td>\nTo ensure proper storage and handling of Chemicals\/Media\/Solvents\/ Poisonous chemicals\/Reference standards\/Working standards as per SOP.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              \u00a0\u00a0\u00a0 5.4<\/strong><\/td>\nResponsibilities of Analyst\/Officer\/Microbiologist:<\/strong><\/td>\n<\/tr>\n
              5.4.1<\/td>\nTo follow Good Laboratory Practices.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.2<\/td>\nSampling and analysis of Raw Materials\/Packing Materials and maintaining records.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.3<\/td>\nAnalysis of In process Samples\/Finished Products and maintaining records.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.4<\/td>\nPreparation of Control Samples of Raw and Packing Materials.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.5<\/td>\nStability Study Analysis as per plan.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.6<\/td>\nSampling and analysis of water and water validation as per plan.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.7<\/td>\nMaintaining records of Instrument\/Equipment usage log.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.8<\/td>\nDiscussing any quality problems with Quality Control Head\/Manager.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.9<\/td>\nCleaning, maintenance and calibration of laboratory Instruments\/Equipments as per schedule.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.10<\/td>\nPreparation of Reagents\/Indicators\/Volumetric Solutions and maintaining records.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.11<\/td>\nProcurement, Storage and Handling of Media\/Chemicals\/Solvents for analysis and maintaining stock and consumption records.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.12<\/td>\nTo follow safety precautions during work.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.13<\/td>\nTo maintain training records up to date.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.14<\/td>\nTo maintain online documentation.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.15<\/td>\nAll time readiness for non-regulatory, regulatory and internal audits.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.16<\/td>\nTo complete analysis and reporting within stipulated time period.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.17<\/td>\nTo file OOS\/Deviation\/Incident.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.18<\/td>\nTo follow and work as per standard operating procedure.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.19<\/td>\nDaily reporting to quality control head\/supervisor.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.20<\/td>\nCareful usage of organisation resources without any wastage.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.21<\/td>\nAny other responsibility assigned by the management as situation demand.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.22<\/td>\nReview of analytical reports.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.23<\/td>\nExecute daily work planning as per Standard Testing Procedure, Specification, Pharmacopoeia etc.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.24<\/td>\nPreparation of new documents like Standard Testing procedures, Specifications, Protocols etc.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.25<\/td>\nPreparation, handling and storage of Reference standards\/Working standards as per SOP.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.26<\/td>\nDaily up keeping of laboratory.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.27<\/td>\nEnvironmental monitoring and maintaining records.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.28<\/td>\nMaintenance of cultures, preparation of subcultures, serial culture dilution, decontamination and maintaining records.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.29<\/td>\nMinimum inhibitory concentration, validation of disinfectants used and maintaining records.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.30<\/td>\nGrowth promotion of media as per SOP and maintaining records.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.31<\/td>\nAfter allotment of Job Responsibilities, update \u2018Employee Job Responsibilities\u2019 as per Annexure<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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

                \n
              1. Definitions \/ Abbreviations: <\/strong><\/li>\n<\/ol>\n
                  \n
                • Definitions:<\/strong><\/li>\n
                • Abbreviations:<\/strong><\/li>\n<\/ul>\n

                  \u00a0<\/strong><\/p>\n\n\n\n\n\n\n\n
                  Abbreviation<\/strong><\/td>\nExpansion<\/strong><\/td>\n<\/tr>\n
                  OOS<\/td>\nOut Of Specification<\/td>\n<\/tr>\n
                  AMC<\/td>\nAnnual Maintenance Call<\/td>\n<\/tr>\n
                  GMP<\/td>\nGood Manufacturing Practices<\/td>\n<\/tr>\n
                  Etc.<\/td>\nExcetra<\/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: Allotment of Job Responsibilities in Quality Control Department Objective: To lay down the procedure for Allotment of Job Responsibilities in Quality Control Department. Scope: This procedure is applicable for Allotment of Job Responsibilities of Analyst, Executive, Supervisor, and Manager in Quality Control Department. Responsibility: Quality Control Department: To prepare and review the SOP. […]<\/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-628","post","type-post","status-publish","format-standard","hentry","category-qc-sop"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/628","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=628"}],"version-history":[{"count":1,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/628\/revisions"}],"predecessor-version":[{"id":629,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/628\/revisions\/629"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=628"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=628"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=628"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}