Checklist in Quality control for Audit Preparation of FDA & USFDA

November 26, 2019January 29, 2023 Pharmaceutical Guidanace

Checklist in Quality control for Audit Preparation of FDA & USFDA

Personnel

Organogram of Quality control departments
List of Employee and education details
Individual Job Description
Training Record of Individual employee as per individual Job Responsibility and Training Log and training assessments records
Analyst Qualification records as per individual Job Responsibility and Organogram
Specimen Signature log of employee.

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Audit and Guideline 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, Alabama, Alagoas, Alaska, 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, Arizona, Arkansas, 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, California, 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, Colorado, Como, COMOROS, CONAKRY, Congleton, CONGO, Connecticut, 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, Delaware, 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, Florida, 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, Hawaii, 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, Idaho, Illinois, Imperia, Indiana, Indonesia, Indore, Inverclyde, Invergordon, Inverness, Iowa, 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, Kansas, KATHMANDU, Katowice urban area, KAZAKHSTAN, Kazan, Kemerovo, Kendal, Kent, Kentucky, 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, Louisiana, 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, Maine, MAJURO, MALABO, malawi, Malaysia, MALDIVES MALE, MALI, MALTA, MANAGUA, MANAMA, Manchester, MANILA, Manitoba, Mantua, Maranhao, Marlborough, Marlow, Marseille, Maryland, Mascara, MASERU, Massa and Carrara, Massachusetts, 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, Michigan, Mid and East Antrim, Mid Ulster, Middlesbrough, Midlothian, Milan, Milford, Milngavie, Milton, Milton Keynes, Minas Gerais, Minnesota, Minsk, Mississippi, Missouri, Modena, MOGADISHU, Monmouthshire, MONROVIA, Montana, 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, Nebraska, Nellore, Nelson, Nepal, Netherlands, Nevada, New Al Hitmi, New Al Mirqab, New Al Rayyan, New Brunswick, New Fereej Al Ghanim, New Fereej Al Khulaifat, New Hampshire, New Jersey, New Mexico, New Plymouth, New Salata, New South Wales, New York, 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 Carolina, North Dakota, 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, Ohio, Oklahoma, Old Al Ghanim, Old Al Hitmi, Old Al Rayyan, oman, Omsk, Onaiza, Ontario, OntarioToronto, Oran, Oregon, 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, Pennsylvania, 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, 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, Rhode Island, 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 Carolina, South Dakota, 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, Tennessee, Teramo, Terni, Texas, 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, Utah, 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, Vermont, Verona, Vibo Valentia, Vicenza, Victoria, Vienna, VIENTIANE, VIETNAM HANOI, Vijayawada, VILNIUS, Virginia, 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 Virginia, West Yorkshire, West Yorkshire (Bradford–Leeds), Western Australia, Western Isles, Westland, Whitehaven, Whitehorse, Wick, Wiltshire, Winchester, Windsor and Maidenhead, Winnipeg, Wisbech, Wisconsin, Wokingham, Wolverhampton, Worcester, Worcestershire, Workington, Wrexham, Wrexham Qatar, Wycombe, Wyoming, YAMOUSSOUKRO, YAOUNDE, YAREN DISTRICT, Yaroslavl, Yellowknife, YEMEN SANA'A ZAMBIA, YEREVAN, York, Yorkshire and the Humber, Yukon, ZAGREB, ZIMBABWE