The Role of Total Quality Management in the Pharmaceutical, Food, and Nutritional Supplement Sectors
Abstract
:1. Introduction
Overview of Total Quality Management (TQM) and Its Importance
2. Materials and Methods
2.1. Literature Review Process
2.2. Bibliometric Analysis
3. Results and Discussion
4. Challenges and Future Directions
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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ISO Standards— Food Industry 1,2 | Title |
---|---|
ISO 22000 | Food safety management systems—Requirements for any organization in the food chain |
ISO 22002-1 | Prerequisite programme on food safety—Part 1: Food manufacturing |
ISO 22003 | Food safety management systems—Requirements for bodies providing audit and certification |
ISO 22004 | Food safety management systems—Guidance on the application of ISO 22000 |
ISO 22005 | Traceability in the feed and food chain—General principles and basic requirements for system design and implementation |
ISO 6887 | Microbiology of the Food Chain Package Parts 1 to 4: ISO 6887-1, ISO 6887-2, ISO 6887-3 and ISO 6887-4 |
ISO/TS 22002 | Academy Food Collection Prerequisite Programs on Food Safety—ISO/TS 22002-1, ISO/TS 22002-2, ISO/TS 22002-3 and ISO/TS 22002-4 |
ISO 22000:2018 | Food Safety Management Systems—A Practical Guide |
ISO 22000, ISO/TS 22003, ISO 22004 and ISO 22005 | Food Safety Package |
ISO 22000:2018 ISO 22000:2018 | Food safety management systems—Requirements for any organization in the food chain |
ISO 22174:2005 | Microbiology of food and animal feeding stuffs—Polymerase chain reaction (PCR) for the detection of food-borne pathogens—General requirements and definitions |
ISO 19020:2017 | Microbiology of the food chain—Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs |
ISO 26642:2010 | Food products—Determination of the glycaemic index (GI) and recommendation for food classification |
ISO 22003-1:2022 | Food safety—Part 1: Requirements for bodies providing audit and certification of food safety management systems |
ISO/TS 17728:2015 | Microbiology of the food chain—Sampling techniques for microbiological analysis of food and feed samples |
ISO/TS 22002-1:2009 | Prerequisite programmes on food safety—Part 1: Food manufacturing |
ISO/TS 22002-4:2013 | Prerequisite programmes on food safety—Part 4: Food packaging manufacturing |
ISO/TS 22002-6:2016 | Prerequisite programmes on food safety—Part 6: Feed and animal food production |
ISO Standards— Pharmaceutical Industry | Title |
ISO 15378 | Primary packaging materials for medicinal products—Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) |
ISO 9001 | Quality management systems—Requirements |
ISO 13485 | Medical devices—Quality management systems—Requirements for regulatory purposes |
ISO 14644-1 | Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration |
ISO 14375:2018 | Child-resistant non-reclosable packaging for pharmaceutical products—Requirements and testing |
ISO 22413:2021 | Transfer sets for pharmaceutical preparations—Requirements and test methods |
ISO 28862:2018 | Packaging—Child-resistant packaging—Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products |
ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use—Part 1: Extractables in aqueous autoclavates |
ISO 8871-2:2020 | Elastomeric parts for parenterals and for devices for pharmaceutical use—Part 2: Identification and characterization |
ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use—Part 5: Functional requirements and testing |
ISO 11418-1:2016 | Containers and accessories for pharmaceutical preparations—Part 1: Drop-dispensing glass bottles |
ISO/HL7 27953-1:2011 | Health informatics—Individual case safety reports (ICSRs) in pharmacovigilance—Part 1: Framework for adverse event reporting |
ISO/HL7 27953-2:2011 | Health informatics—Individual case safety reports (ICSRs) in pharmacovigilance—Part 2: Human pharmaceutical reporting requirements for ICSR |
ISO Standards— Nutritional Supplement Industry | Title |
ISO 22000 | Food safety management systems—Requirements for any organization in the food chain |
ISO 9001 | Quality management systems—Requirements |
ISO 22716 | Cosmetics — Good Manufacturing Practices (GMP)—Guidelines on Good Manufacturing Practices |
ISO 22579:2020 | Infant formula and adult nutritionals—Determination of fructans—High performance anion exchange chromatography with pulsed amperometric detection (HPAEC-PAD) after enzymatic treatment |
ISO 20636:2018 | Infant formula and adult nutritionals—Determination of vitamin D by liquid chromatography-mass spectrometry |
ISO 20637:2015 | Infant formula and adult nutritionals—Determination of myo-inositol by liquid chromatography and pulsed amperometry |
ISO 20647:2015 | Infant formula and adult nutritionals—Determination of total iodine—Inductively coupled plasma mass spectrometry (ICP-MS) |
ISO 21422:2018 | Milk, milk products, infant formula and adult nutritionals—Determination of chloride—Potentiometric titration method |
ISO 4214:2022 | Milk and milk products—Determination of amino acids in infant and adult/paediatric nutritional formulas and dairy products |
ISO 15151:2018 | Milk, milk products, infant formula and adult nutritionals—Determination of minerals and trace elements—Inductively coupled plasma atomic emission spectrometry (ICP-AES) method |
ISO 16958:2015 | Milk, milk products, infant formula and adult nutritionals—Determination of fatty acids composition—Capillary gas chromatographic method |
ISO 20633:2015 | Infant formula and adult nutritionals—Determination of vitamin E and vitamin A by normal phase high performance liquid chromatography |
ISO 20634:2015 | Infant formula and adult nutritionals—Determination of vitamin B12 by reversed phase high performance liquid chromatography (RP-HPLC) |
ISO 20635:2018 | Infant formula and adult nutritionals—Determination of vitamin C by (ultra) high performance liquid chromatography with ultraviolet detection ((U)HPLC-UV) |
ISO 20639:2015 | Infant formula and adult nutritionals—Determination of pantothenic acid by ultra high performance liquid chromatography and tandem mass spectrometry method (UHPLC-MS/MS) |
ISO 20649:2015 | Infant formula and adult nutritionals—Determination of chromium, selenium and molybdenum—Inductively coupled plasma mass spectrometry (ICP-MS) |
ISO 21424:2018 | Milk, milk products, infant formula and adult nutritionals—Determination of minerals and trace elements—Inductively coupled plasma mass spectrometry (ICP-MS) method |
ISO 21446:2019 | Infant formula and adult nutritionals—Determination of trans and total (cis + trans) vitamin K1 content—Normal phase HPLC |
ISO 21468:2020 | Infant formula and adult nutritionals—Determination of free and total choline and free and total carnitine—Liquid chromatography tandem mass spectrometry (HPLC-MS/MS) |
ISO 21470:2020 | Infant formula and adult nutritionals—Simultaneous determination of total vitamins B1, B2, B3 and B6—Enzymatic digestion and LC-MS/MS |
ISO 23305:2020 | Fortified milk powders, infant formula and adult nutritionals—Determination of total biotin by liquid chromatography coupled with immunoaffinity column clean-up extraction |
ISO 23443:2020 | Infant formula and adult nutritionals—Determination of ?-carotene, lycopene and lutein by reversed-phase ultra-high performance liquid chromatography (RP-UHPLC) |
ISO 20784:2021 | Sensory analysis—Guidance on substantiation for sensory and consumer product claims |
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Vassos, V.; Voltezou, A.; Stavropoulos, A.; Stavropoulou, E.; Stefanis, C.; Tsigalou, C.; Nena, E.; Chatzaki, E.; Constantinidis, T.C.; Bezirtzoglou, E. The Role of Total Quality Management in the Pharmaceutical, Food, and Nutritional Supplement Sectors. Foods 2024, 13, 2606. https://doi.org/10.3390/foods13162606
Vassos V, Voltezou A, Stavropoulos A, Stavropoulou E, Stefanis C, Tsigalou C, Nena E, Chatzaki E, Constantinidis TC, Bezirtzoglou E. The Role of Total Quality Management in the Pharmaceutical, Food, and Nutritional Supplement Sectors. Foods. 2024; 13(16):2606. https://doi.org/10.3390/foods13162606
Chicago/Turabian StyleVassos, Vassilios, Agathi Voltezou, Agathangelos Stavropoulos, Elisavet Stavropoulou, Christos Stefanis, Christina Tsigalou, Evangelia Nena, Ekaterini Chatzaki, Theodoros C. Constantinidis, and Eugenia Bezirtzoglou. 2024. "The Role of Total Quality Management in the Pharmaceutical, Food, and Nutritional Supplement Sectors" Foods 13, no. 16: 2606. https://doi.org/10.3390/foods13162606