{"id":896,"date":"2025-06-21T14:43:24","date_gmt":"2025-06-21T14:43:24","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=896"},"modified":"2025-06-21T14:43:24","modified_gmt":"2025-06-21T14:43:24","slug":"sop-title-product-manufacturing-quality-plan","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=896","title":{"rendered":"SOP Title: Product Manufacturing Quality Plan"},"content":{"rendered":"

SOP Title: Product Manufacturing\u00a0 Quality Plan<\/u><\/strong><\/p>\n

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

    To lay down procedure for systematic work plan for quality control of product manufacturing process to assure specified product quality attributes.<\/p>\n

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

      This procedure is applicable to quality control plan for all stages of product manufacturing cycle i.e. RM\/PM receipt, testing, storage, dispensing, batch manufacturing, packing and release.<\/p>\n

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

        Concerned Department: Responsible to follow the procedure for operation and control material\/product at each stage.<\/p>\n

        QA Department: Responsible to prepare, review and approve the procedure and ensure that the procedures and control points are being followed.<\/p>\n

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

          Head QA\/All Department<\/p>\n

            \n
          1. Procedure:<\/strong><\/li>\n<\/ol>\n
              \n
            • Definitions:<\/strong><\/li>\n
            • QA Associate:<\/strong> Executive\/officer or any person trained of Quality Assurance Department as per this SOP.<\/li>\n
            • Production Associate:<\/strong> Executive\/officer or any person trained of Production Department as per this SOP.<\/li>\n
            • QC Associate:<\/strong> Executive officer of Quality Control Department or the personnel trained to perform duties as per this SOP.<\/li>\n
            • Warehouse Associate:<\/strong> Executive officer of Warehouse Department or the personnel trained to perform duties as per this SOP.<\/li>\n
            • Procedure:<\/strong><\/li>\n<\/ul>\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
              5.2.1<\/td>\nAll incoming materials shall be checked for physical damages, labelling and quantity requirements. Then the material shall be segregated as per the approved procedure, GRN & MCR of received material shall be sent to QC Department.<\/td>\n <\/td>\n<\/tr>\n
              5.2.2<\/td>\nBased on the GRN & MCR received from warehouse inspection and sampling of incoming material shall be performed and material shall be labelled with yellow colour \u201cUNDER TEST\u201d label.<\/td>\n <\/td>\n<\/tr>\n
              5.2.3<\/td>\nThe sampled incoming material shall be \u00a0entered in the laboratory log book (separate for Raw & Packing materials), analyzed by Quality Control Analyst with IP, BP, EP,USP or In-house Specification.<\/td>\n <\/td>\n<\/tr>\n
              5.2.4<\/td>\nThe sample is analysed and all analysis results shall recorded in AWR (Analytical Work Record) log sheets and COA shall be prepared.<\/td>\n <\/td>\n<\/tr>\n
              5.2.5<\/td>\nBased on AWR, a report Raw Materials and Packing Materials shall be labelled with green (APPROVED) label or red (REJECTED) label depends on the status.<\/td>\n <\/td>\n<\/tr>\n
              5.2.6<\/td>\nA portion of API shall be retained as Control Sample as per approved procedure.<\/td>\n <\/td>\n<\/tr>\n
              5.2.7<\/td>\nOnly Approved Raw Materials shall be dispensed and used for manufacturing process.<\/td>\n <\/td>\n<\/tr>\n
              5.2.8<\/td>\nBefore start up of manufacturing process QA line clearance should be taken as per procedure to avoid contamination, cross-contamination and mix-up.<\/td>\n <\/td>\n<\/tr>\n
              5.2.9<\/td>\nDuring each stage of manufacturing respective product BMR\/BPR shall be available. All the manufacturing processes shall be carried with relevant BMR and BPR. Manufacturing process shall be carried out in direct supervision of competent technical staff.<\/td>\n <\/td>\n<\/tr>\n
              5.2.10<\/td>\nDuring manufacturing initial and in-process checks shall be carried out as per product BMR\/BPR.<\/td>\n <\/td>\n<\/tr>\n
              5.2.11<\/td>\nAll process materials in the processing area should be stored in specified closed container with proper labels.<\/td>\n <\/td>\n<\/tr>\n
              5.2.12<\/td>\nSampling of in-process product shall be carried and tested. After release of in-process bulk products, product shall be forwarded to further stage\/activity.<\/td>\n <\/td>\n<\/tr>\n
              5.2.13<\/td>\nTesting of bulk material shall be carried out as per product specification.<\/td>\n <\/td>\n<\/tr>\n
              5.2.14<\/td>\nIn case of any non-compliance, it shall be notified, investigated and corrected through proper documentation system.<\/td>\n <\/td>\n<\/tr>\n
              5.2.15<\/td>\nThe Finished Product is sampled and tested as per IP, BP, EP, USP & In-house specification<\/td>\n <\/td>\n<\/tr>\n
              5.2.16<\/td>\nOn analysis of the Finished Product, all data is recorded in Analytical work Record sheet.<\/td>\n <\/td>\n<\/tr>\n
              5.2.17<\/td>\nA portion of the Finished Product is retained as \u2018Control Sample\/Retention Sample\u2019 and record shall be maintained.<\/td>\n <\/td>\n<\/tr>\n
              5.2.18<\/td>\nBased on the details of AWR, COA shall be prepared and copy shall be sent to QA.<\/td>\n <\/td>\n<\/tr>\n
              5.2.19<\/td>\nThe finally packed Finished Goods shall be inspected and a final inspection report is prepared.<\/td>\n <\/td>\n<\/tr>\n
              5.2.20<\/td>\nThe retained Control Samples are randomly checked for any physical changes and randomly batches are kept for stability.<\/td>\n <\/td>\n<\/tr>\n
              5.2.21<\/td>\nAll batch related records shall be retained for a minimum period one year after expiry of the product unless there is any regulatory commitment.<\/td>\n <\/td>\n<\/tr>\n
              5.2.22<\/td>\nThe Finished Product shall be inspected and released by the authorized person.<\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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

                \n
              1. Abbreviation: <\/strong><\/li>\n<\/ol>\n\n\n\n\n\n\n\n\n\n\n\n\n
                Abbreviation:<\/strong><\/td>\nExpansion<\/strong><\/td>\n<\/tr>\n
                QA<\/td>\nQuality Assurance<\/td>\n<\/tr>\n
                QC<\/td>\nQuality Control<\/td>\n<\/tr>\n
                BP<\/td>\nBritish Pharmacopoeia<\/td>\n<\/tr>\n
                EP<\/td>\nEuropean Pharmacopoeia<\/td>\n<\/tr>\n
                USP<\/td>\nUnited State Pharmacopeia<\/td>\n<\/tr>\n
                IP<\/td>\nIndian Pharmacopoeia<\/td>\n<\/tr>\n
                AWR<\/td>\nAnalytical Work Record<\/td>\n<\/tr>\n
                MCR<\/td>\nMaterial Control Record<\/td>\n<\/tr>\n
                GRN<\/td>\nGoods Receipts Note<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\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","protected":false},"excerpt":{"rendered":"

                SOP Title: Product Manufacturing\u00a0 Quality Plan Objective: To lay down procedure for systematic work plan for quality control of product manufacturing process to assure specified product quality attributes. Scope: This procedure is applicable to quality control plan for all stages of product manufacturing cycle i.e. RM\/PM receipt, testing, storage, dispensing, batch manufacturing, packing and release. […]<\/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":[8],"tags":[],"class_list":["post-896","post","type-post","status-publish","format-standard","hentry","category-quality-assurance"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/896","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=896"}],"version-history":[{"count":1,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/896\/revisions"}],"predecessor-version":[{"id":897,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/896\/revisions\/897"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=896"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=896"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=896"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}