SOP Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material in Pharma

July 20, 2016November 23, 2024 Pharmaceutical Guidanace

SOP Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material in Pharma

Objective: To lay down a procedure for the approval of vendors for raw & packing material and De-qualification and Re-qualification of existing approved vendors.

Scope: This Standard Operating Procedure is applicable for vendor qualification, De-qualification and Re- qualification of raw material & packing material to be followed.

Responsibility

In-charge of Purchase department or his authorized nominee is responsible for identification and selection of vendor.

In-charge of QA department or his authorized nominee is responsible for evaluation and audit of vendor.

In-charge of QC department or his authorized nominee is responsible for analysis of samples.

Head of QA department or his authorized nominee is responsible for the approval/rejection of vendor.

Accountability: Department Head & QA Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions

SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
QA : Quality Assurance
QC : Quality Control
CoA :Certificate of Analysis

Procedure

The Head QA shall coordinate the vendor qualification process with Manager Purchase and other relevant departments.

Manager Purchase shall initiate the vendor qualification process for additional / alternative vendor(s) to the existing material(s).

Based on the reputation, quality standards and marketing trend analysis, Purchase Department initiate to make a possible new vendor list for each material.

Manager Purchase shall forward the vendor qualification questionnaire along with the current material specification obtained from QA and sent to the respective vendor(s).

The vendor qualification questionnaire (Annexure- I) consists of three parts.

Part A-Basic information (Site details, contact numbers, Production capacity, turn over, Organization performance, major customers etc.)
Part B-Technical information of the manufacturing site
Part C-Product specific information

For qualification questionnaire shall be sent to the vendor as stated below:

Complete (Part A, B & C) qualification questionnaire shall be sent to all vendors.
For the qualification of the new material from existing qualified vendor of the same site, Part C of qualification questionnaire along with specification shall be sent.

Vendor approval procedure for raw and packing material shall be as follows:

Vendor Approval for Raw Material

The Manager Purchase shall obtain the filled questionnaire and one pre-shipment sample along with certificate of analysis and minimum three COAs from different batches.

The sample shall be analyzed as per current specifications by QC department. The results along with any other relevant comments shall be communicated to Head QA.

The Head QA shall assess the vendor based on the filled vendor qualification questionnaire against statutory and in house requirements along with the analytical results of the pre shipment sample.

Based on the compliance of statutory and in house requirements, the vendor shall be considered as qualified.

A vendor audit shall carried out jointly by Manager Purchase, Head QA and Manager Production whenever necessary as per Annexure II.

Wherever vendor audit shall be carried out, the final technical assessment of the vendor shall be done on the percentage score of the vendor from the Vendor Quality Audit Check list.

A vendor shall be considered as qualified if the score is 80% or above.

If the score is below 80%, corrective actions shall be suggested for system/facility updating.

Only after confirmation of the corrective actions the vendor shall be qualified.

All the vendors for the existing material shall be qualified by sending the qualification questionnaire and on the past performance.

Vendor Approval for Packing Material

The Manager Purchase shall obtain the filled questionnaire and at least one certificate of analysis from the vendors to check the tests carried out at the vendor end and shall communicate the same to Head QA.

The Head QA will assess the vendor based on the filled vendor qualification questionnaire and the certificate of analysis.

Based on the compliance of requirements indicated in the questionnaire, the vendor shall be approved.

Packing Materials shall be classified into the following categories namely:

Primary Packing Material

Secondary Packing Material

Tertiary Packing Material

A vendor Audit shall be carried out for primary printed and unprinted packing material as per vendor quality audit checklist (Annexure –II) by a vendor audit team comprising of representatives from Quality Assurance, Quality Control and Production Department as applicable.

Wherever possible / applicable Machine suitability test shall be carried out on pre shipment sample to check the suitability of the component. In absence of pre shipment sample, Machine suitability trial shall be carried out on first supply. Observations of the Machine suitability test shall be documented.

Vendor Audit shall be carried out as per vendor Audit checklist as per Annexure-II.

Vendor Approval certificate as per Annexure III, shall be issued to Manager Purchase, Manager Quality control and In-charge Warehouse.

Once the vendor qualifies in the technical assessment the Manager Purchase shall in parallel evaluate the commercial aspects.

The list of Approved Vendors as per Annexure IV shall be updated quarterly and further procurement of the material shall be carried out. The performance of the approved vendors shall review annually through assessment of history records of Vendors (Annexure-V).

Whenever there is a revision in the Raw material specifications, revised specifications shall be forwarded to the respective vendors through Purchase Department.

Purchase Department shall ensure the revised specification forwarded to the supplier before procuring the material from the effective date of specification.

Disqualification of Vendor

The Approved Vendor shall be Dis-qualified, if the vendor is not able to provide consistent quality product as per the specification consecutively for three times.

In the first rejection of a consignment of any material, the supplier shall be cautioned through the ‘caution/warning’ letter as per Annexure –VI, and shall be asked for a detailed investigation report, if the rejected parameter is not serious in nature. The further procurement of the material shall be kept under hold till the receipt of the investigation report.

Intimation shall be forwarded to the purchase department through ‘Vendor Activation/Deactivation Form’ (Annexure -VIII).

If the rejected parameter is serious in nature e.g. E.coli present, Assay failure, vendor site audit shall be conducted to identify the root cause for failure.

The further procurement of the material shall be kept under hold till the receipt of the investigation report highlighting corrective action plan from the vendor.

Vendor compliance shall be evaluated against vendor site audit report. If any targeted dates found in the compliance report, follow up audit / correspondence shall be conducted based upon the criticality.

After satisfactory completion of evaluation as per Annexure –VII (Vendor Assessment form), the vendor shall be re activated by sending a written communication Annexure -VIII (Vendor Activation/Deactivation form) to the purchase department.

Note: Activation of the supplies shall only be given when all the corrective actions have been completed.

In the second instance of rejection of any material of the vendor from the same manufacturing site, a ‘caution/warning’ letter shall be issued as per Annexure–VI, Followed by re audit of the facility to identify the root cause for non-compliance.

The following disqualifications criteria shall be adopted in case if vendor is supplying more than one material from one site:

If the failure is originated from Quality system the vendor shall be disqualified.

If the failure is process related the products manufactured from that site of vendor shall be disqualified.

Above procedure shall be followed.

After satisfactory completion of evaluation as per Annexure-VII, the vendor shall be activated by sending a written communication Annexure VIII (Vendor Activation / Deactivation form) to the purchase department.

If any Material is rejected for the third consecutive time from the vendor at the same manufacturing site, then the vendor shall be ‘Black Listed’, with a notification to Manager Purchase, In-charge Warehouse, Manager Quality Control and a copy to the vendor through purchase department.

The Approved Vendor List shall be updated quarterly and as on when a vendor is qualified or de qualified as per Annexure – IV.

Approved vendor list shall be stamped as ‘Master Copy’

The document controller shall take photocopy of ‘Master Copy’ and stamped as ‘Controlled Copy’ as described in SOP.

Procedure for Provisional approval of vendor

In case of any urgent as per the market requirement the vendor will be provisionally approved as per the following (applicable only for excipients):

Purchase department in consultation with Head QA and Head QC to decide the vendor

Vendor’s agreement to supply material meeting the ‘Specification’

Review of vendor CoAs

Other commercial terms

In such case commercial lot from the provisionally approved vendor will be considered as vendor sample. Based on these considerations the vendor shall be provisionally approved vendor.

Vendor documentation for provisionally approved vendor shall be completed before second commercial consignment and then the vendor shall be consider as approved vendor.

Re-qualification of Vendors

Vendor shall be re-qualified once in two years based upon the history of earlier supplies.

If rejections, caution / warning letters found in the vendor history record, vendor shall be re-qualified followed by vendor site audit.

If the vendor is out-side the country, fresh questionnaire shall be issued and based upon the information, the vendor shall be qualified.

Forms and Records (Annexures)

Vendor Qualification questionnaire (Part –A, B (RM) & B (PM) and C) – Annexure I
Vendor Quality audit check list -Annexure II
Vendor Approval certificate -Annexure III
List of approved vendors -Annexure IV
History Cards of Vendors -Annexure V
Caution / Warning Letter -Annexure VI
Vendor assessment form -Annexure VII
Vendor activation / Deactivation form -Annexure VIII
Check List for Provisionally approved vendor -Annexure IX

Distribution

Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control & Warehouse

History

Date	Revision Number	Reason for Revision
–	–	New SOP

Quality Assurance 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

SOP Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material in Pharma

Note: Activation of the supplies shall only be given when all the corrective actions have been completed.

Reason for Revision

More Related Articles

Do Not Sell My Personal Information