{"id":771,"date":"2025-06-14T13:34:34","date_gmt":"2025-06-14T13:34:34","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=771"},"modified":"2025-06-14T13:34:34","modified_gmt":"2025-06-14T13:34:34","slug":"sop-title-analytical-data-review-and-result-transcription","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=771","title":{"rendered":"SOP Title: Analytical Data Review and Result Transcription"},"content":{"rendered":"

SOP Title:<\/u><\/strong> Analytical Data Review and Result Transcription<\/u><\/strong><\/p>\n

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

    To lay down the procedure for Analytical Data Review and Result Transcription in the Quality Control Department.<\/p>\n

     <\/p>\n

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

      This procedure is applicable for Analytical Data Review and Result Transcription in the Quality Control Department.<\/p>\n

       <\/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 Analytical Data Review and Result Transcription in Quality Control Department as per this SOP.<\/li>\n
        • Quality Assurance Department: To review and approve the SOP and Annexure.<\/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

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

              \n
            1. Procedure:<\/strong><\/li>\n<\/ol>\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
              5.1\u00a0\u00a0\u00a0 <\/strong>\u00a0<\/strong><\/td>\nCompilation of Analytical Data:<\/strong><\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nAnalysis shall be carried out as per standard testing procedure and reporting of results shall be carried out with respect to specification.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nAll raw data like printouts of weight prints, chromatograms, spectrum, and contract testing laboratories reports shall be affixed.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.3\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nRaw data sheet and all weight prints, chromatograms, spectrum shall be signed by the analyst and reviewed by reviewer.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.4\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nEnsure that all entries shall be in respective log Books during analysis.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.5\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nAll relevant information shall be filled in respective raw data sheet.<\/td>\n <\/td>\n<\/tr>\n
              5.1.6\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nEnsure that always use the current lot of working standard and reference standard, wherever applicable.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nEnsure that correct factor used during the water content testing with Karl Fischer Titrator and correct molarity with Automatic Potentiometer Titrator.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.8\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nAnalytical results shall be carry forward to next stage in case of dose form of product is same like; results of coated tablets, uncoated tablet, Filled capsules, cream and ointment shall be transcribed during analysis finished product, wherever applicable.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.9\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nEnsure that reference A.R. No. shall be mentioned in finished product report during the transcription of results from respective stage.<\/p>\n

               <\/td>\n

              		 <\/td>\n<\/tr>\n
              5.1.10\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nIn case data transcribed from previous stage, ensure that at least description and identification test to be carried out.<\/td>\n <\/td>\n<\/tr>\n
              5.1.11\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nIn case, identification test to be done for finished product by HPLC then, one Blank, one standard and one sample shall be injected in the HPLC.<\/td>\n <\/td>\n<\/tr>\n
              5.1.12\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nIn case, only identification test to be done for raw material by HPLC\/GC then, one Blank, one standard and one sample shall be injected in the HPLC\/GC.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.13\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nMicro analysis shall be carried out in finished pack, if applicable.<\/td>\n <\/td>\n<\/tr>\n
              5.1.14\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nIf any customer, ask for the complete test after packing then all test shall be carried out after packing.<\/td>\n <\/td>\n<\/tr>\n
              \u00a0\u00a0\u00a0 5.2<\/strong><\/td>\nReview of Analytical Data :<\/strong><\/td>\n<\/tr>\n
              5.2.1\u00a0 \u00a0<\/strong><\/td>\nPerson having sufficient experience or subject expert shall be responsible for review of analytical data.<\/td>\n <\/td>\n <\/td>\n<\/tr>\n
              5.2.2\u00a0 \u00a0<\/strong><\/td>\nEnsure that all relevant details of tested materials \/ product entered in raw data sheet.<\/td>\n <\/td>\n <\/td>\n<\/tr>\n
              5.2.3\u00a0 \u00a0<\/strong><\/td>\nEnsure that all the relevant entries made in the respective log books.<\/td>\n <\/td>\n <\/td>\n<\/tr>\n
              5.2.4\u00a0 \u00a0<\/strong><\/td>\nEnsure that analysis is completed as per respective current specification.<\/td>\n <\/td>\n <\/td>\n<\/tr>\n
              5.2.5\u00a0 \u00a0<\/strong><\/td>\nEnsure that use of working standard and its potency is as per current\/effective working standard.<\/td>\n <\/td>\n <\/td>\n<\/tr>\n
              5.2.6\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nEnsure that analysis has been completed by using the corrected HPLC\/GC columns.<\/td>\n <\/td>\n<\/tr>\n
              5.2.7\u00a0 \u00a0<\/strong><\/td>\nEnsure that all print outs \/ chromatograms \/ spectrum duly signed and dated by analyst and attached with raw data sheet.<\/td>\n <\/td>\n<\/tr>\n
              5.2.8\u00a0 \u00a0<\/strong><\/td>\nEnsure that correct Normality\/Molarity of volumetric solution is used.<\/td>\n <\/td>\n<\/tr>\n
              5.2.9\u00a0\u00a0 \u00a0<\/strong><\/td>\nEnsure that correct factor is used for water content testing by using Karl Fischer.<\/td>\n <\/td>\n<\/tr>\n
              5.2.10\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nEnsure that all units mentioned correctly in raw data sheet.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.11\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nRounding of digits shall be done as per SOP \u2018Rounding and Reporting of Test Results\u2019.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.12\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nEnsure the correctness of calculations.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.13 \u00a0<\/strong><\/td>\nReviewer shall check all raw data attached with report for its correctness and accuracy.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.14\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nReviewer shall put the signature along with date on raw data sheet.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.15\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nReviewer shall sign and date raw data, wherever applicable.<\/td>\n <\/td>\n<\/tr>\n
              5.2.16\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nAlways follow approved specification and standard testing procedure for the review of document.<\/td>\n <\/td>\n<\/tr>\n
              \u00a0 5.3<\/strong><\/td>\nReviewer Certification:<\/strong><\/td>\n<\/tr>\n
              5.3.1\u00a0 \u00a0<\/strong><\/td>\nBefore reviewing any data, reviewer shall be assessed by his\/her supervisor to check sufficient knowledge and understanding of relevant records possessed by that particular person.<\/td>\n <\/td>\n<\/tr>\n
              5.3.2\u00a0 \u00a0<\/strong><\/td>\nSupervisor shall allocate one complete current analytical report for checking to the reviewer to do the assessment of his\/her reviewing skills.<\/td>\n <\/td>\n<\/tr>\n
              5.3.3\u00a0 \u00a0<\/strong><\/td>\nAfter completion of review of analytical report, supervisor shall re-check same analytical report for its correctness and accuracy.<\/td>\n <\/td>\n<\/tr>\n
              5.3.4\u00a0 \u00a0<\/strong><\/td>\nIf all data reviewed by new reviewer and supervisor are matching then supervisor shall recommend to the new reviewer for certification as per Annexure.<\/td>\n <\/td>\n<\/tr>\n
              5.3.5\u00a0 \u00a0<\/strong><\/td>\nFinally certification of reviewer shall be done by Head Quality Control\/Designee.<\/td>\n <\/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<\/ul>\n

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

                    \n
                  • Abbreviations :<\/strong><\/li>\n<\/ul>\n\n\n\n\n\n\n
                    Abbreviation<\/strong><\/td>\nExpansion<\/strong><\/td>\n<\/tr>\n
                    SOP<\/td>\nStandard Operating Procedure<\/td>\n<\/tr>\n
                    QC<\/td>\nQuality Control<\/td>\n<\/tr>\n
                    QA<\/td>\nQuality Assurance<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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

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

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

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

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

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

                    \u00a0<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

                    SOP Title: Analytical Data Review and Result Transcription Objective: To lay down the procedure for Analytical Data Review and Result Transcription in the Quality Control Department.   Scope: This procedure is applicable for Analytical Data Review and Result Transcription in the 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-771","post","type-post","status-publish","format-standard","hentry","category-qc-sop"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/771","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=771"}],"version-history":[{"count":1,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/771\/revisions"}],"predecessor-version":[{"id":772,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/771\/revisions\/772"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=771"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=771"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=771"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}