GMP requirements from the FDA

GMP requirements from the FDA

FDA Good Manufacturing Practices (GMP) is a set of guidelines issued by the FDA for various disciplines. There are GMP requirements FDA has for areas ranging from cosmetics to food to pharmaceuticals to API’s.

Why GMP’s?

Why are GMP requirements FDA has put in place necessary? It is for the simple reason that they are good manufacturing practices, and these practices have evolved over time. Being the regulatory body for the US; the FDA has to put a few practices into place, which will help manufacturers and consumers alike get the best out of a product.

Not the same as manufacturing process

It has to be understood that GMP’s are a set of guidelines, and are hence not to be confused with scientific literature or research that goes into a manufacturing process. GMP requirements FDA has are actually a product of many years of observation of the manufacturing process, whose implementation helps a product achieve its best results. GMP in itself is not a complete science, but a set of thumb rules that help manufacturers get the best out of their products.

Current good manufacturing practices

GMP requirements FDA has prescribed are collectively called by the term “current good manufacturing practices’, and are categorized under two headings:

  • Modernization of Food Good Manufacturing Practice Regulations
  • Dietary Supplement CGMPs

These are part of GMP requirements FDA has for the drug and food industries, which it regulates. These are contained in Title 21: Food and Drugs – PART 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.

References:

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=cefdff5373327b34dfa6f87642959825&rgn=div5&view=text&node=21:2.0.1.1.10&idno=21

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/CurrentGoodManufacturingPracticesCGMPs/default.htm

http://en.wikipedia.org/wiki/Good_manufacturing_practice

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