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SOP on Precautions during on line maintenance of machine and re-start operation. Objective: To lay down a procedure for precautions during on line maintenance of machine and checks to start its operation.
Scope: The standard operating procedure is applicable for formulation plant of Pharmaceutical company.
Responsibility
Production Supervisor / Officer / Executive shall be responsible for implementation of this procedure.
Head-Production / designee shall be responsible for compliance of the procedure as per this SOP.
Accountability:
Head-Production and head QA shall be accountable for compliance of the procedure as per this SOP.
Abbreviations and Definitions: Type-A -Product to Product cleaning procedure
Type-B – Batch to Batch cleaning procedure
Procedure
Switch ‘OFF’ the machine when online maintenance shall be required.
Prepare the maintenance memo with detailed nature of breakdown and forward it to the engineering department.
Cover the online product or material collecting containers with the lid and keep them aside on a pallet.
Allow the engineering person to perform the maintenance work. After the completion of the maintenance work ensure that the maintenance is done properly.
Clean the machine with cleaning procedure Type-A if contact parts included in the maintenance or otherwise clean the machine with cleaning procedure Type-B.
If the maintenance work of machine / equipment continues for more than 24 hours remove the material / product from respective machine and transfer the material in containers duly labeled as per current version of SOP. to the quarantine.
Clean the whole machine / equipment with cleaning procedure Type-A.
After completion of cleaning switch ‘ON’ the machine.
Run the machine in empty condition to check for the satisfactory maintenance work.
In case of time specified for manufacturing / packing operation, after the maintenance work of the relevant equipment gets completed, carry out the manufacturing operation for remaining period of time left out for completion of operation.
Record the details of machine / equipment breakdown in relevant machine logbook..
If printers attached to the PLC based equipment or weighing balance are under maintenance then record the data of the process manually in the space provided in respective BMR.
In case of compression / filling operation, collect the tablets of first 2 to 3 rotations as rejected residues with proper label on their polybags.
In case of compression / filling operation, take the new sample after the machine trial and again check the in process parameters of tablets / capsules and record in the BMR of respective product.
Distribution
Master Copy – Documentation Cell (QA)
Controlled Copies – Production, Quality Assurance
Date Revision
Number
Reason for revision
–
00
New SOP
Categories Production Tags Aberdeen , Aberdeenshire , Abu Dhabi , Abu Dhalouf , Abu Hamour , Abu Samra , ABUJA , ACCRA , Acre , Ad Dawhah al Jadidah , ADDIS ABABA , Adelaide , AFGHANISTAN , Agra , Agrigento , Ahmedabad , Aïn Beïda , Ain Khaled , Ain Sinan , Ajman , Ajman and Ra’s al-Khaimah , Ajmer , Al Ain , Al Aziziya , Al Bidda , Al Daayen , Al Dafna , Al Ebb , Al Egla , Al Gharrafa , Al Ghuwariyah , Al Hilal , Al Jasrah , Al Jeryan , Al Karaana , Al Kharaitiyat , Al Kharayej , Al Kharrara , Al Kheesa , Al Khor , Al Khulaifat , Al Luqta , Al Mamoura , Al Mansoura , Al Markhiyah , Al Mashaf , Al Masrouhiya , Al Mearad , Al Messila , Al Mirqab , Al Najada , Al Nasraniya , Al Qassar , Al Rufaa , Al Sadd , Al Sailiya , Al Sakhama , Al Seej , Al Shagub , Al Souq , Al Tarfa , Al Thakhira , Al Themaid , Al Thumama (Al Wakrah) , Al Thumama (Doha) , Al Utouriya , Al Waab , Al Wajba , Al Wakrah , Al Wukair , Al Zubarah , Al-Shahaniya , Alagoas , ALBANIA , Alberta , Alessandria , ALGERIA , Algiers , Aligarh , Allahabad , Allerdale , Amapa , Amazonas , Amber Valley , Amersham , AMMAN , Ampthill , Amravati , Amritsar , Amsterdam , Amur , Ancona , and Craigavon , and Down , ANDORRA , ANDORRA LA VELLA , ANGOLA , Angus , ANKARA , Annaba , ANTANANARIVO , ANTIGUA & BARBUDA , Antrim and Newtownabbey , Antwerp , Aosta , APIA , Ar Ru'ays , Ards and North Down , ARGENTINA , Argyll and Bute , Arkhangelsk , Arlington , Armagh , ARMENIA , As Salatah , Ascoli Piceno , Ashbourne , ASHGABAT , ashington , Ashland , Ashmore and Cartier Islands , ASMARA , Asti , Astrakhan , ASUNCIÓN , Athens , Auckland , Aurangabad , australia , Australian Antarctic Territory , Australian Capital Territory , Austria , Avellino , Aylesbury , Aylesbury Vale , AZERBAIJAN , Baaya , BAGHDAD , BAHAMAS , Bahia , BAHRAIN , BAKU , BAMAKO , Banbridge , BANDAR SERI BEGAWAN , Bangalore , BANGKOK , Bangladesh , Bangor , BANGUI , Bani Hajer , BANJUL , Barahat Al Jufairi , BARBADOS , Barcelona , Bareilly , Bari , Barletta-Andria-Trani , Barrow-in-Furness , BASSETERRE , Bath , Batna , Bavaria , Beaconsfield , Béchar , Bedford , BEIJING , BEIRUT , Béjaïa , Belarus , Belfast , Belgium , Belgorod , Belgrade , BELIZE , Belluno , BELMOPAN , Belper , Benevento , BENIN , Bergamo , Berlin , BERN , Bhavnagar , Bhilai Nagar , Bhiwandi , Bhopal , Bhubaneswar Salem , BHUTAN , Biella , Bikaner , Birmingham , Birmingham (West Midlands) , BISHKEK , Biskra , BISSAU , Blackburn with Darwen , Blackpool , Blaenau Gwent , Blida , BLOEMFONTEIN , Bloomsbury , Bodmin , BOGOTÁ , BOLIVIA , Bologna , Bolsover , Bordj Bou Arreridj , BOSNIA & HERZEGOVINA , BOTSWANA , Bou Saâda , Bournemouth , Bracknell Forest , Bradford , BRASILIA , BRATISLAVA , brazil , BRAZZAVILLE , Bremen , Brescia , Bridgend , BRIDGETOWN , Brighton , Brighton and Hove , Brindisi , Brisbane , Bristol , British Columbia , BRUNEI , BRUSSELS , Brussels-Capital Region , Bryansk , Bu Fasseela , Bu Samra , Bu Sidra , Bucharest , Buckinghamshire , Budapest , BUENOS AIRES , BUJUMBURA , Bulgaria , BURKINA FASO , Burlington , BURUNDI , Buxton , CABO VERDE , Caerphilly , Cagliari , CAIRO , Caltanissetta , CAMBODIA , Cambridge , Cambridgeshire , Camden , CAMEROON , Campobasso , canada , Canberra , Canterbury , CAPE TOWN , Cardiff , Carlisle , Carmarthenshire , Caserta , CASTRIES , Catania , Catanzaro , Causeway Coast and Glens , Ceara , Centerville , CENTRAL AFRICAN REPUBLIC , Central Bedfordshire , Ceredigion , CHAD , Chalfont St. Giles , Chandigarh , Charlottetown , Chelmsford , Chelyabinsk , Chennai , Cheshire East , Cheshire West and Chester , Chester , Chesterfield , Chichester , Chieti , CHILE , Chiltern , China , Chlef , Christmas Island , City of London , Clackmannanshire , Clayton , Cleveland , Clinton , Clydebank , Coatbridge , Cockermouth , Cocos (Keeling) Islands , Coimbatore , Coldstream , colombia , COLOMBO , Como , COMOROS , CONAKRY , Congleton , CONGO , Constantine , Conwy , Copeland , Copenhagen , Coral Sea Islands , Cornwall , Cosenza , COSTA RICA , CÔTE D'IVOIRE(Ivory Coast) , Coventry , Cremona , Crewe , CROATIA , Cromarty , Crotone , CUBA , Cumbernauld , Cumbria , Cuneo , Cuttack , CYPRUS , Czech Republic , CZECH REPUBLIC (Czechia) , Dahl Al Hamam , DAKAR , Dalkeith , DAMASCUS , Darlington , Darwin , Dayton , Dehradun Garhwali , Delhi , Denbighshire , denmark , Derby , Derbyshire , Derbyshire Dales , Derry , Derry and Strabane , Devon , DHAKA , Djelfa , DJIBOUTI , DJIBOUTI (CITY) , DODOMA , Doha , Dombivali , DOMINICA , DOMINICAN REPUBLIC , Donetsk , Dorset , Dover , dubai , Dublin , Duhail , Dukhan , Dumfries and Galloway , Dunbar , Dundee , Dunkeld , Duns , Dunstable , Durgapur Asansol , Durham , DUSHANBE , East Ayrshire , East Devon , East Dunbartonshire , EAST JERUSALEM , East Lothian , East Midlands , East of England , East Renfrewshire , East Riding of Yorkshire , East Sussex , ECUADOR , Eden , Edinburgh , Edmonton , Egypt , El Eulma , El Oued , EL SALVADOR , Elgin , Ely , England , Enna , EQUATORIAL GUINEA , Erewash , ERITREA , Espirito Santo , Essex , estado , estados , ESTONIA , ESWATINI (formerly Swaziland) , ETHIOPIA , Exeter , Fairview , Falkirk , Falmouth , Faridabad , Fenland , Fereej Abdel Aziz , Fereej Al Amir , Fereej Al Asiri , Fereej Al Asmakh , Fereej Al Manaseer , Fereej Al Murra , Fereej Al Nasr , Fereej Al Soudan , Fereej Al Zaeem , Fereej Bin Durham , Fereej Bin Mahmoud , Fereej Bin Omran , Fereej Kulaib , Fereej Mohammed Bin Jassim , Fermanagh and Omagh , Fermo , Ferrara , Fife , FIJI , Finland , Firozabad , Flintshire , Florence , Foggia , Forlì-Cesena , Forres , Fort William , Fowey , france , Frankfurt Rhine-Main Region , Franklin , Fredericton , FREETOWN SINGAPORE , Frosinone , Fujairah , FUNAFUTI , Fuwayrit , GABON , GABORONE , Galashiels , GAMBIA , Genoa , Georgetown , Georgia , Germany , GHANA , Gharrafat Al Rayyan , Ghaziabad , Glasgow , Gloucester , Gloucestershire , Goias , Gorakhpur , Gorizia , Grasmere , Greater Glasgow , Greater London , Greater Manchester , greece , Greenock , Greenville , GRENADA , Grosseto , GUATEMALA , GUATEMALA CITY , Guelma , GUINEA , GUINEA-BISSAU , Gujarati , Gulbarga , Guntur , Gurgaon , Guwahati , GUYANA , Gwalior , Gwynedd , Haddington , HAITI , Halifax , Halton , Hamad Medical City , Hamburg , Hampshire , Haora , HARARE , Hartlepool , HAVANA , Hawick , Hawke's Bay , Hazm Al Markhiya , Heard Island and McDonald Islands , Helsinki , Helston , Hereford , Herefordshire , Hertfordshire , Hesse , High Peak , High Wycombe , Highland , Hobart , HONDURAS , HONIARA , Hove , Hubli and Dharwad , Hudson , Hungary , Huntingdon , Huntingdonshire , hyderabad , ICELAND , Imperia , Indonesia , Indore , Inverclyde , Invergordon , Inverness , Iqaluit , Iran , Iraq , ireland , Irkutsk , Irvine , Isernia , ISLAMABAD , Isle of Anglesey , Isle of Wight , Isles of Scilly , ISRAEL , Istanbul , Italy , Ivanovo , Izghawa (Al Rayyan) , Izghawa (Umm Salal) , Jabal Thuaileb , Jabalpur , Jackson , Jaipur , JAKARTA , Jalandhar , jamaica , Jammu , Jamnagar , Jamshedpur , japan , Jelaiah , JERUSALEM , Jervis Bay Territory , Jeryan Jenaihat , Jeryan Nejaima , Jhansi , Jijel , Jodhpur , jordan , JUBA , KABUL , Kaliningrad , Kaluga , Kalyan , KAMPALA , Kanpur , KATHMANDU , Katowice urban area , KAZAKHSTAN , Kazan , Kemerovo , Kendal , Kent , KENYA , Keswick , Kharkiv , KHARTOUM , Khawr al Udayd , Kiev , KIGALI , Kingston , Kingston upon Hull , KINGSTOWN , Kinross , KINSHASA , KIRIBATI , Kirkintilloch , Kirkwall , Kirov , Knutsford , Kochi , Kolkata , KOSOVO , Kostroma , Kota , Kraków , KUALA LUMPUR , Kurgan , Kursk , kuwait , KUWAIT CITY , KYRGYZSTAN , L'Aquila , La Spezia , Laghouat , Lancashire , Lancaster , LAOS , Latina , LATVIA , Launceston , Leabaib , Lebanon , Lebday , Lecce , Lecco , Leeds , Leicester , Leicestershire , Lejbailat , Lekhwair , Leningrad , Leqtaifiya (West Bay Lagoon) , LESOTHO , Lexington , LIBERIA , LIBREVILLE , LIBYA , Lichfield , LIECHTENSTEIN , Lijmiliya , Lille–Kortrijk–Tournai France/ Belgium , LILONGWE , LIMA , Lincoln , Lincolnshire , Lipetsk , Lisbon , Lisburn , Lisburn and Castlereagh , LITHUANIA , Liverpool , Livorno , LJUBLJANA , LOMÉ , london , Loni , Looe , Lossiemouth , Lostwithiel , Luaib , LUANDA , Lucca , Lucknow , Ludhian , Lusail , LUSAKA , Luton , LUXEMBOURG , M'Sila , Macclesfield , Macerata , MADAGASCAR , Madinat Al Kaaban , Madinat ash Shamal , Madinat Khalifa North , Madinat Khalifa South , Madison , Madrid , Madurai , Magadan Moscow , Maghnia , MAJURO , MALABO , malawi , Malaysia , MALDIVES MALE , MALI , MALTA , MANAGUA , MANAMA , Manchester , MANILA , Manitoba , Mantua , Maranhao , Marlborough , Marlow , Marseille , Mascara , MASERU , Massa and Carrara , Matera , Matlock , Mato Grosso , Mato Grosso do Sul , MAURITANIA , mauritius , MBABANE , Mebaireek , Médéa , Medway , Meerut , Mehairja , Melbourne , Merseyside , Merthyr Tydfil , Mesaieed , Mesaimeer , Messina , Mexico , MEXICO CITY , Mid and East Antrim , Mid Ulster , Middlesbrough , Midlothian , Milan , Milford , Milngavie , Milton , Milton Keynes , Minas Gerais , Minsk , Modena , MOGADISHU , Monmouthshire , MONROVIA , MONTEVIDEO , Monza and Brianza , Moradabad , Moray , MORONI , Moscow , Mostaganem , Motherwell and Wishaw , Mount Vernon , Mourne , Muaither , Mumbai , Muraikh , Murmansk , MUSCAT , Mushayrib , Mysore , N'DJAMENA , Nagpur , NAIROBI , Najma , NAMIBIA WINDHOEK , Nanded Kolapur , Nantwich , Naples , Nashik , NASSAU , NAURU , Navi Mumbai , Neath Port Talbot , Nellore , Nelson , Nepal , Netherlands , New Al Hitmi , New Al Mirqab , New Al Rayyan , New Brunswick , New Fereej Al Ghanim , New Fereej Al Khulaifat , New Plymouth , New Salata , New South Wales , new Zealand , Newfoundland and Labrador , Newport , NewportAuburn , Newquay , Newry , NGERULMUD , NIAMEY , NICARAGUA , NICOSIA , NIGER , Nigeria , Nizhniy Novgorod , Nizhny , Noida , Norfolk , Norfolk Island , North , North Ayrshire , North East Derbyshire , North East Lincolnshire , NORTH KOREA , North Lanarkshire , North Lincolnshire , NORTH MACEDONIA , North Somerset , North West , North Yorkshire , Northamptonshire , Northern , Northern Ireland , Northern Territory , Northumberland , Northwest Territories , Northwich , Norway , Norwich , Nottingham , Nottinghamshire , NOUAKCHOTT , Nova Scotia , Novara , Novgorod , Novosibirsk , Nu`ayjah , Nunavut , Nuoro , NUR-SULTAN , Nuremberg , Oakland , Old Al Ghanim , Old Al Hitmi , Old Al Rayyan , oman , Omsk , Onaiza , OntarioToronto , Oran , Orenburg , Oristano , Orkney Islands , Oryol , OSLO , Otago , Ottawa , OUAGADOUGOU , Ouargla , Oxford , Oxfordshire , Padua , Paisley , Pakistan , PALAU , Palermo , PALESTINE , PANAMA , PANAMA CITY , PAPUA NEW GUINEA , Para , PARAGUAY , Paraiba , PARAMARIBO , Parana , Paris , Parma , Patna , Pavia , Pembrokeshire , Penrith , Penryn , Penza , Penzance , Pernambuco , Perth , Perth and Kinross , peru , Perugia , Pesaro and Urbino , Pescara , Peterborough , Philippines , PHNOM PENH , Piacenza , Piaui , Pimpri , Pisa , Pistoia , Plymouth , Poland , Poole , Pordenone , PORT LOUIS , PORT MORESBY , PORT OF SPAIN , PORT VILA , PORT-AU-PRINCE , Porto Portugal , PORTO-NOVO , Portsmouth , portugal , Potenza , Powys , Prague , PRAIA , Prato , Preston , PRETORIA , Prince Edward Island , PRISTINA , Pskov , Pune , PYONGYANG , Qatar , Quebec City , Queensland , QUITO , Ragusa , Raipur , Rajkot , Ramsey , Ranchi , Ras Abu Aboud , Ras Al Khaimah , Ras Lafan , Ravenna , Rawdat Al Hamama , Rawdat Al Khail , Rawdat Egdaim , Rawdat Rashed , Reading , Redcar and Cleveland , Reggio Calabria , Reggio Emilia , Regina , Relizane , Renfrew , Renfrewshire , Repton , REYKJAVIK , Rhondda Cynon Taf , Rieti , RIGA , Rimini , Rio de Janeiro , Rio Grande , Ripon , Riverside , RIYADH , Romania , Rome , ROSEAU , Rostov , Rotterdam , Rovigo , Rumeilah , Russia , Rutland , RWANDA , Ryazan , Saharanpur , Saïda , SAINT GEORGE'S , SAINT JOHN'S , SAINT KITTS & NEVIS , SAINT LUCIA , Saint Petersburg , SAINT VINCENT & THE GRENADINES , Sakhalin , Salem , Salerno , Salford , Salisbury , Saltash , Samara , SAMOA , SAN JOSE , SAN MARINO , SAN SALVADOR , Sandhurst , SANTIAGO , SANTO DOMINGO , SÃO TOMÉ & PRÍNCIPE , SÃO TOMÉ SAUDI ARABIA , SARAJEVO , Saratov , Saskatchewan , Sassari , Savona , Sawda Natheel , Saxony , Scotland , Scottish Borders , SENEGAL , SEOUL , Serbia , Sétif , Seville , SEYCHELLES , Shagra , Sharjah , Sheffield , Shetland Islands , Shropshire , Sidi bel Abbès , Siena , SIERRA LEONE , Siliguri , Simaisma , singular , Skikda , SKOPJE , Slough , SLOVAKIA , SLOVENIA , Smolensk , Sofia , Solapur , SOLOMON ISLANDS , SOMALIA , Somerset , Sondrio , Souk Ahras , SOUTH AFRICA , South Australia , South Ayrshire , South Bucks , South Cambridgeshire , South Derbyshire , South East , South Gloucestershire , SOUTH KOREA , South Lakeland , South Lanarkshire , South Sardinia , SOUTH SUDAN , SOUTH TARAWA , South Tyrol , South West , South Yorkshire , Southampton , Southend-on-Sea , Southland , spain , Springfield , SRI JAYAWARDENEPURA KOTTE , Sri Lanka , Srinagar , St Albans , St Asaph , St Davids , St. Austell , St. Ives , St. John's , Staffordshire , Stirling , STOCKHOLM , Stockton-on-Tees , Stoke Poges , Stoke-on-Trent , Stuttgart , SUCRE , sudan , Suffolk , Sunderland , Surat , SURINAME , Surrey , SUVA , Sverdlovsk , Swansea , Sweden , Swindon , switzerland , Sydney , Syracuse , SYRIA , TAJIKISTAN , TALLINN , Tambov , TANZANIA , Taranto , TASHKENT , Tasmania , TBILISI , Tébessa , TEGUCIGALPA , TEHRAN , Telford , Telford and Wrekin , Teramo , Terni , Thailand , Thane , The Hague , The Pearl , THIMPHU , Thiruvananthapuram , Thuringia , Thurrock , Thurso , Tiaret , TIMOR-LESTE DILI , Tintagel , TIRANA , Tiruchirappalli , Tizi Ouzou , Tlemcen , TOGO , TOKYO , Tomsk , TONGA NUKUʻALOFA , Torbay , Trapani , Trento , Treviso , Trieste , TRINIDAD & TOBAGO , TRIPOLI , Truro , Tula , TUNIS , TUNISIA , Turin , turkey , TURKMENISTAN , TUVALU , Tver , Tyne and Wear , Tyumen , Udine , UGANDA , Ujjain , Ukraine , Ukraine. Dnipropetrovsk , Ulhasnagar , Ulyanovsk , Umm al-Qaiwain , Umm al-Quwain , Umm Bab , Umm Birka , Umm Ghuwailina , Umm Lekhba , Umm Qarn , Umm Salal Ali , Umm Salal Mohammed , United arab emirates , UNITED ARAB EMIRATES (UAE) , united Kingdom , UNITED KINGDOM* (UK) , United States , UNITED STATES OF AMERICA (USA) , URUGUAY , UZBEKISTAN , Vadodara , VADUZ , Vale of Glamorgan , Valencia , VALLETTA MARSHALL ISLANDS , VANUATU , Varanasi , Varese , Vasai Virar , VATICAN CITY , VATICAN CITY (Holy See) , VENEZUELA CARACAS , Venice , Verbano-Cusio-Ossola , Vercelli , Verona , Vibo Valentia , Vicenza , Victoria , Vienna , VIENTIANE , VIETNAM HANOI , Vijayawada , VILNIUS , Visakhapatnam , Viterbo , Vladimir , Volgograd , Vologda , Voronezh , Wadi Al Banat , Wadi Al Sail , Wadi Al Wasaah , Wadi Lusail , Wakefield , Wales , Warrington , Warsaw , Warwickshire , Washington , Wellington , Wells , West Berkshire , West Dunbartonshire , West Lothian , West Midlands , West Sussex , West Yorkshire , West Yorkshire (Bradford–Leeds) , Western Australia , Western Isles , Westland , Whitehaven , Whitehorse , Wick , Wiltshire , Winchester , Windsor and Maidenhead , Winnipeg , Wisbech , Wokingham , Wolverhampton , Worcester , Worcestershire , Workington , Wrexham , Wrexham Qatar , Wycombe , YAMOUSSOUKRO , YAOUNDE , YAREN DISTRICT , Yaroslavl , Yellowknife , YEMEN SANA'A ZAMBIA , YEREVAN , York , Yorkshire and the Humber , Yukon , ZAGREB , ZIMBABWE , Zürich
