{"id":892,"date":"2025-06-21T14:37:39","date_gmt":"2025-06-21T14:37:39","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=892"},"modified":"2025-06-21T14:39:54","modified_gmt":"2025-06-21T14:39:54","slug":"sop-title-emergency-power-failure","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=892","title":{"rendered":"SOP Title: Emergency Power Failure"},"content":{"rendered":"<p><strong><u>SOP Title:<\/u><\/strong><u> <strong>Emergency Power Failure<\/strong><\/u><\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<ol>\n<li><strong>Objective<\/strong><\/li>\n<\/ol>\n<p>To lay down procedure for actions to be taken in case of emergency power failure during critical operations at the site<\/p>\n<ol start=\"2\">\n<li><strong>Scope:<\/strong><\/li>\n<\/ol>\n<p>This procedure is applicable to Production and Quality Control area<\/p>\n<ol start=\"3\">\n<li><strong>Responsibility:<\/strong><\/li>\n<\/ol>\n<p>Production Associate: To inform the incident to senior and follow the procedure<\/p>\n<p>QA Associate: To verify, inform the incident to senior and follow the procedure<\/p>\n<p>Engineering Associate: To verify, review, identify the cause of incident and take necessary actions<\/p>\n<p>QC Associate: To inform the incident to senior and follow the procedure<\/p>\n<ol start=\"4\">\n<li><strong>Accountability:<\/strong><\/li>\n<\/ol>\n<p>Head QA\/All head of departments<\/p>\n<ol start=\"5\">\n<li><strong>Procedure:<\/strong><\/li>\n<\/ol>\n<p><strong>5.1\u00a0 Definitions:<\/strong><\/p>\n<p><strong>Emergency Power:<\/strong> Electricity temporarily produced and supplied by a standby power generator when the conventional electric power supply fails or is interrupted.<\/p>\n<p><strong>Emergency Power Failure:<\/strong> Failure of standby power generator to supply electric power which in turn causes the equipment to shut down.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>5.2 Procedure<\/strong><\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"66\">5.2.1<\/td>\n<td colspan=\"2\" width=\"602\"><strong>Actions to be taken during manufacturing of product (dispensing, granulation, compression ,blending, capsule filling, Packing etc) in Production Department in case of emergency power failure <\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.1<\/td>\n<td width=\"583\">Switch off the mains of machine and record the time of processing\/activity or operation.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.2<\/td>\n<td width=\"583\">Remove or unload the material in proper manner in clean poly bag\/container, tie\/cover, label, segregate etc as applicable.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.3<\/td>\n<td width=\"583\">Inform immediate supervisor\/department head.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.4<\/td>\n<td width=\"583\">Fill the \u2018Complaint Note\u2019 and submit to Engineering Department.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.5<\/td>\n<td width=\"583\">Fill the \u2018Incident Report Form\u2019 and submit to Quality Assurance Department.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.6<\/td>\n<td width=\"583\">Start further process\/activity only after decision made through incident assessment.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.7<\/td>\n<td width=\"583\">After resumption of the power, check temperature, relative humidity and pressure differential of the area as per BMR\/BPR.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.8<\/td>\n<td width=\"583\">Switch ON the main, check the equipment for correct operation, process parameter, product parameters etc.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.9<\/td>\n<td width=\"583\">Start further activity\/operation\/process for remaining time period to continue the process.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.1.10<\/td>\n<td width=\"583\">Record the details in the respective BMR\/BPR and Equipment\u00a0 Log.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\"><strong>5.2.2<\/strong><\/td>\n<td colspan=\"2\" width=\"602\"><strong>Actions to be taken during testing operation of products (chemical, instrumental, microbiological etc) in Quality Control \u00a0Department in case of emergency power failure<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.1<\/td>\n<td width=\"583\">Sophisticated equipment\/instruments shall be provided with untripped power supply in the Quality Control laboratory.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.2<\/td>\n<td width=\"583\">For others switch off the mains of equipment\/instrument and record the time of operation\/activity in case of emergency power failure.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.3<\/td>\n<td width=\"583\">Inform immediate Supervisor\/Department Head.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.4<\/td>\n<td width=\"583\">Fill the \u2018Complaint Note\u2019 and submit to Engineering department.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.5<\/td>\n<td width=\"583\">Fill the \u2018Incident Report Form\u2019 and submit to Quality Assurance Department.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.6<\/td>\n<td width=\"583\">Start\u00a0 further testing operation\/activity only after decision made through incident assessment based on impact on testing parameters.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.7<\/td>\n<td width=\"583\">After resumption of the power, check temperature, relative humidity and pressure differential of the area as applicable<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.8<\/td>\n<td width=\"583\">Switch ON the main, check the equipment\/instrument for correct operation, parameter etc.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.9<\/td>\n<td width=\"583\">Stabilise the solution for sample and continue the operation as per procedure.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.2.10<\/td>\n<td width=\"583\">Record the details in the respective worksheet and Instrument\u00a0 Log<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\"><strong>5.2.3<\/strong><\/td>\n<td width=\"583\"><strong>General Points:<\/strong><\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.3.1<\/td>\n<td width=\"583\">An immediate decision shall be taken on the basis of impact assessment regarding further processing\/activity of product to reduce risk to the product quality during emergency power failure.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.3.2<\/td>\n<td width=\"583\">Alternate equipment\/processing step may be considered if applicable, through deviation when there is no significant impact product quality attributes.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.3.3<\/td>\n<td width=\"583\">Incident report should address comprehensive evaluation, analysis, investigation, action plan\u00a0 and implementation with necessary recommendation to prevent such incident in future.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.3.4<\/td>\n<td width=\"583\">Specific assistance in investigation of root cause and corrective actions related to technical\/mechanical or functional error or failure of standby power generator by external engineer or expert may be considered suitable as suggested by Engineering Head, if applicable.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.3.5<\/td>\n<td width=\"583\">A copy of incident report shall be attached to the respective product BMR\/BPR after completion or closing of incident.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<tr>\n<td width=\"66\">5.2.3.6<\/td>\n<td width=\"583\">If the incident emergency power failure found frequent as a result of inefficient system\/service for emergency power supply and\/or modification or replacement of system is required, it should be brought to the notice of management for implementation of new efficient system.<\/td>\n<td width=\"18\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ol start=\"6\">\n<li><strong>Abbreviation: <\/strong><\/li>\n<\/ol>\n<p><strong>\u00a0<\/strong><\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"144\"><strong>Abbreviation<\/strong><\/td>\n<td width=\"360\"><strong>Expansion<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"144\">QAP<\/td>\n<td width=\"360\">Quality Assurance Procedure<\/td>\n<\/tr>\n<tr>\n<td width=\"144\">HVAC<\/td>\n<td width=\"360\">Heating Ventilation and Air Conditioning<\/td>\n<\/tr>\n<tr>\n<td width=\"144\">BMR<\/td>\n<td width=\"360\">Batch Manufacturing Record<\/td>\n<\/tr>\n<tr>\n<td width=\"144\">BPR<\/td>\n<td width=\"360\">Batch Packing Record<\/td>\n<\/tr>\n<tr>\n<td width=\"144\">QAD<\/td>\n<td width=\"360\">Quality Assurance Department<\/td>\n<\/tr>\n<tr>\n<td width=\"144\">SOP<\/td>\n<td width=\"360\">Standard Operating Procedure<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p><strong><em><u>*Note &#8211; Ready to use SOP available in \u201cDOWNLOAD\u201d Section.<\/u><\/em><\/strong><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>SOP Title: Emergency Power Failure \u00a0 Objective To lay down procedure for actions to be taken in case of emergency power failure during critical operations at the site Scope: This procedure is applicable to Production and Quality Control area Responsibility: Production Associate: To inform the incident to senior and follow the procedure QA Associate: To [&hellip;]<\/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-892","post","type-post","status-publish","format-standard","hentry","category-quality-assurance"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/892","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=892"}],"version-history":[{"count":3,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/892\/revisions"}],"predecessor-version":[{"id":895,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/892\/revisions\/895"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=892"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=892"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=892"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}