Hazard analysis and critical control points (HACCP)
Hazard analysis and risk-based preventive controls (HARPC)
Critical control point
Critical factors
FAT TOM
pH
Water activity (aw)
Bacterial pathogens
Clostridium botulinum
Escherichia coli
Listeria
Salmonella
Vibrio cholerae
Cronobacter spp
Viral pathogens
Enterovirus
Hepatitis A
Norovirus
Rotavirus
Parasitic pathogens
Cryptosporidium
Entamoeba histolytica
Giardia
Trichinella
v
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Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages,[1] cosmetics,[2] pharmaceutical products,[3] dietary supplements,[4] and medical devices.[5] These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user.[2] Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase.[2] GMP is typically ensured through the effective use of a quality management system (QMS).[1]: "The Basis for GMP", [2]
Good manufacturing practices, along with good agricultural practices, good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, India and other countries.
^ abInstitute of Food Science & Technology (2013). Food and Drink - Good Manufacturing Practice - A Guide to its responsible management. London: Wiley-Blackwell. ISBN 9781118318232 – via Google Books (Preview).
^ abcdMoore, Iain (2009). "Chapter 5: Manufacturing Cosmetic Ingredients According to Good Manufacturing Principles". In Lintner, Karl (ed.). Global Regulatory Issues for the Cosmetic Industry. Vol. 2. Norwich, New York: William Andrew. pp. 79–92. ISBN 9780815519645 – via Google Books (Preview).
^Nally, J.D., ed. (2007). Good Manufacturing Practices for Pharmaceuticals (6th ed.). CRC Press. p. 424. ISBN 9781420020939.
^"Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide". U.S. Food and Drug and Administration. 12 November 2017. Retrieved 2 February 2018.
^Ramakrishna, S.; Tian, L.; Wang, C.; et al., eds. (2015). "Chapter 3.: Quality management systems for medical device manufacture". Medical Devices: Regulations, Standards and Practices. Woodhead Publishing Series in Biomaterials. Vol. 103. Elsevier. pp. 49–64. ISBN 9780081002919.
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