Good manufacturing practice

Food safety
Terms
Critical factors
Bacterial pathogens
Viral pathogens
Parasitic pathogens

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.

Good Manufacturing Practice emerged in response to serious incidents of harm caused by contaminated, adulterated, or improperly manufactured products. Major incidents include: deaths from Elixir Sulfanilamide in 1937, thalidomide-induced birthdefects 1957-1961, poliomyelitis infections from improperly prepared vaccines in 1955, and Dalkon Shield-induced septicemia in the 1970's.

These incidents resulted in hundreds of deaths, infections, and birth defects. Complete timelines show the emergence of Good Manufacturing Practices alongside these incidents, starting from 1938 in the US and 1970s internationally.[6]

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 practice, along with good agricultural practice, good laboratory practice and good clinical practice, are overseen by regulatory agencies in the United Kingdom, United States, Canada, various European countries, China, India and other countries.

  1. ^ a b Institute 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).
  2. ^ a b c d Moore, 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).
  3. ^ Nally, J.D., ed. (2007). Good Manufacturing Practices for Pharmaceuticals (6th ed.). CRC Press. p. 424. ISBN 9781420020939.
  4. ^ "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.
  5. ^ 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.
  6. ^ "Why does Good Manufacturing Practice exist?". SystemValidation. Retrieved 29 September 2024.