Skip to content
Objective:
To lay down a procedure for operation of labeling machine of pharmaceutical company.
Scope:
This SOP is applicable for sticker labeling machine.
Responsibility:
Production operator / Technician – responsible for operation of machine.
Production officer / Executive – to ensure that operation of the machine is carried out as per SOP.
Accountability:
Production Head and QA Head shall be accountable for the compliance of SOP.
Abbreviations
SOP : Standard Operating Procedure.
No.: Number
Batch No: Batch Number
Mfg: Manufacturing
Exp. Date: Expiry Date
Procedure:
Check the status of the machine for its operation.
Visually check the machine and surrounding area for cleanliness.
Visually check that there is no material of the previous batch / product present.
Write the Batch No., Product Name, Date and signature on the machine status tag.
Take line clearance from production/in process quality assurance officers before starting the labeling operation and enter the line clearance in batch production record.
Get the coding details of the products such as Batch No., Mfg. Date, Exp. Date & Maximum retail price from production officer.
Take the stickers label roll from the production officer as per the secondary packing material requisition.
Start up:
“Switch ON” the mains electric supply to the machine.
Set the sticker label roll on the label spool shaft provided on the labeling machine.
Visually check missing label sensor and No label no vial sensor is properly working.
Setting procedure:
Auto range sensor (Orange colour): Keep sticker label in front of orange sensor then press Orange auto range sensor up to 10 seconds. Blinking of lights will start; again press auto range sensor for 02 seconds orange light will glow then output comes.
Label sensor (Blue colour): Simultaneously press (+) and (–) button on the label, till red light blinking continuously, then press (-) button on the release paper of the roll when yellow light will glow automatically it means output given to the background of the label and also ensure that if labels not available in front of sensor then machine should stop automatically.
Note: If background colour of the sticker label changes, the setting of label sensor is again required.
No Label no vial sensor (Yellow colour): Before starting of the machine check No label no vial sensor is working or not if not then set the sensor according to height of the vials .During setting check the Green light should come right side of the vial neck and output goes to sensor for stop the machine when without vials label passes through conveyor.
Set the inkjet printer according to printing position as per SOP.
Set the coding impression by ink jet printers and get the coding details, take approval from production/ quality assurance and attach the specimen sample of label in the batch production record.
Frequency:
Before start of new batch or days operation.
On completion of batch or days operation.
Whenever a new label roll is used for labeling.
Before and after of every joint in sticker label roll.
Operation:
Load vials on the in feed turn table to labeling machine.
Switch “ON” the machine and run without vials.
Operate the labeling machine and label 5 filled vials.
Get the labeled vials Approved from production/ in process quality assurance officers.
After getting the Approvals continue the labeling operation
Set the sticker label roll with a new one after completion of the previous roll.
Continue the operation till completion of batch.
If sticker label roll have more then two joints in – between the roll, it should not be allowed.
Shut down:
After completion of the batch /days work, switch “off” the labeling machine.
Remove the left over label roll at the end of the day’s operation. If the labeling of the batch is to be continued on the next days pack the label roll in poly bags and store under lock and key.
Collect and count the rejected sticker label in poly bag.
Destroy and dispose off rejected labels.
Switch “off” the main electric supply and air supply to the machine.
Record the operation, cleaning and maintenance details in the equipment log book as per SOP get it checked by production officer
Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
History
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 , european countries , 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 , Myaanmar (Burma) , 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 , ontario canada , 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 state , 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