QUALITY RISK MANAGEMENT (QRM)

December 30, 2020November 16, 2024 Pharmaceutical Guidanace

QUALITY RISK MANAGEMENT (QRM)

Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug products across the product lifecycle, systems, utilities, facility and other associated aspects.

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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, 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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, 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NIAMEY, NICARAGUA, NICOSIA, NIGER, Nigeria, Nizhniy Novgorod, Nizhny, Noida, Norfolk, Norfolk Island, North Ayrshire, North East, North East Derbyshire, North East Lincolnshire, NORTH KOREA, North Lanarkshire, North Lincolnshire, NORTH MACEDONIA, North Somerset, North West, North Yorkshire, Northamptonshire, 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, 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, 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, Wycombe, YAMOUSSOUKRO, YAOUNDE, YAREN DISTRICT, Yaroslavl, Yellowknife, YEMEN SANA'A ZAMBIA, YEREVAN, York, Yorkshire and the Humber, Yukon, ZAGREB, ZIMBABWE, Zürich

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