{"id":900,"date":"2025-06-21T14:50:26","date_gmt":"2025-06-21T14:50:26","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=900"},"modified":"2025-06-21T14:50:26","modified_gmt":"2025-06-21T14:50:26","slug":"sop-title-equipment-machinery-maintenance","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=900","title":{"rendered":"SOP Title: Equipment & Machinery Maintenance"},"content":{"rendered":"

SOP Title: Equipment & Machinery Maintenance<\/u><\/strong><\/p>\n

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

    To lay down procedure for preventive maintenance requirement and providing effective maintenance to machinery\/equipments in the facility to ensure proper functioning.<\/p>\n

      \n
    1. Scope: <\/strong>This procedure is applicable to:<\/li>\n<\/ol>\n
        \n
      • Installation of new machinery and complete trial.<\/li>\n
      • Routine breakdown maintenance.<\/li>\n
      • Periodical preventive maintenance.<\/li>\n
      • Periodical servicing of the machinery\/equipment.<\/li>\n<\/ul>\n
          \n
        1. Responsibility:<\/strong><\/li>\n<\/ol>\n

          Head Concerned Department:<\/strong> Shall be responsible for identifying the requirement of maintenance as per schedule and compliance thereof.<\/p>\n

          Head Engineering:<\/strong> Shall be responsible for the timely execution of the maintenance and maintaining records thereof.<\/p>\n

          Plant Head:<\/strong> Shall be responsible for approval of the machinery and spares requirement and purchase thereof.<\/p>\n

          Head QA: <\/strong>Shall be responsible for preparing and approval of maintenance procedure and ensuring compliance thereof.<\/p>\n

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

            Head QA, Engineering and Concerned Department.<\/p>\n

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

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

              5.1\u00a0 Definitions:<\/strong><\/p>\n

              Preventive Maintenance: <\/strong>Preventative Maintenance is maintenance that is regularly performed on a piece of equipment to lessen the likelihood of it failing. Preventative maintenance is performed while the equipment is still working, so that it does not break down unexpectedly.<\/p>\n

              Breakdown Maintenance: <\/strong>Breakdown maintenance is maintenance performed on equipment that has broken down or proper working\/operation stopped unexpectedly.<\/p>\n

              Concerned Department: <\/strong>Department in which the equipment or machinery is installed and operated and maintenance responsibility lies with.<\/p>\n

              5.2\u00a0 Procedure:<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
              5.2.1<\/strong><\/td>\nMaintenance Program: <\/strong>Maintenance program shall include following aspects:<\/td>\n<\/tr>\n
              5.2.1.1<\/td>\nEquipment used in manufacturing, processing, testing, packaging and holding of drug product where applicable.<\/td>\n <\/td>\n<\/tr>\n
              5.2.1.2<\/td>\nProvisions shall be made for notification to Concerned Department for maintenance schedule.<\/td>\n <\/td>\n<\/tr>\n
              5.2.1.3<\/td>\nMaintenance operation should not compromise product quality.<\/td>\n <\/td>\n<\/tr>\n
              5.2.1.4<\/td>\nMechanism for production supervision to notify maintenance of potential problems.<\/td>\n <\/td>\n<\/tr>\n
              5.2.1.5<\/td>\nMechanism for Engineering to notify maintenance requirements\/ spares to rectify\/prevent potential problems.<\/td>\n <\/td>\n<\/tr>\n
              5.2.1.6<\/td>\nType of maintenance work required i.e. electrical, mechanical and civil.<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.<\/strong><\/td>\nMaintenance Procedure<\/strong><\/td>\n <\/td>\n<\/tr>\n
              5.2.2.1<\/td>\nAll machines shall be provided with Log Book, wherein the operational status of the machinery is recorded.<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.2<\/td>\nWhenever a breakdown occurs, a complaint note in complaint format shall be sent to the Engineering Department.<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.3<\/td>\nAll general maintenance jobs shall be performed as per written procedure.<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.4<\/td>\nAfter completion of the maintenance job, the complainant shall sign the copy of the complaint note, in proof thereof.<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.5<\/td>\nIf spares are required, proper indent shall be given to Stores (Maintenance).<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.6<\/td>\nPeriodical maintenance and servicing of the machinery shall be done as per written procedure. Preventive maintenance schedule shall be prepared for all process equipment \/ machinery and records maintained, following written procedure.<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.7<\/td>\nMachines, which are under annual maintenance contract, shall be repaired by the concerned agency as specified in the list of approved service contractors.<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.8<\/td>\nCivil maintenance is done periodically under the supervision of Head Administration<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.9<\/td>\nRecords for the repairs, servicing etc., as and when required, in the Machine Maintenance and Service Records.<\/td>\n <\/td>\n<\/tr>\n
              5.2.2.10<\/td>\nAll critical equipment including LAF, sampling and dispensing booths, balances, HVAC, boilers, RO-EDI water plant, dehumidifiers, stability chambers and compressors are maintained under annual service maintenance contract.<\/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
                Abbreviation<\/strong><\/td>\nExpansion<\/strong><\/td>\n<\/tr>\n
                HVAC<\/td>\nHeating, Ventilation and Air Conditioning<\/td>\n<\/tr>\n
                LAF<\/td>\nLaminar Air Flow<\/td>\n<\/tr>\n
                i.e.<\/td>\nId Est (that is)<\/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","protected":false},"excerpt":{"rendered":"

                SOP Title: Equipment & Machinery Maintenance Objective: To lay down procedure for preventive maintenance requirement and providing effective maintenance to machinery\/equipments in the facility to ensure proper functioning. Scope: This procedure is applicable to: Installation of new machinery and complete trial. Routine breakdown maintenance. Periodical preventive maintenance. Periodical servicing of the machinery\/equipment. Responsibility: Head Concerned […]<\/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-900","post","type-post","status-publish","format-standard","hentry","category-quality-assurance"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/900","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=900"}],"version-history":[{"count":1,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/900\/revisions"}],"predecessor-version":[{"id":901,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/900\/revisions\/901"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=900"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=900"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=900"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}