What Is a GMP Environment?

Written by jesse broadt
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What Is a GMP Environment?
Manufacturers must adhere to GMP guidelines. (factory image by cico from Fotolia.com)

Good manufacturing practice--otherwise known as GMP--guidelines have been established by the U.S Food and Drug Administration to uphold standards outlined for the manufacturing of drugs and other products.

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Food manufacturers, pharmaceutical companies and biotech firms are required to maintain a GMP environment by adhering to FDA guidelines for these practices. GMP guidelines ensure products meet quality standards during manufacturing in four areas: identity, purity, quality and strength.


The FDA has implemented specific guidelines for GMPs concerning the development and manufacturing of drugs. This involves a sliding scale used in conjunction with the particular phase of a drug's development. In what is considered phase one of a drug's advancement, the regulations can be followed more loosely, but once a product reaches phase three and manufacturing begins, strict adherence to GMPs is expected.

Global Considerations

According to the European Compliance Academy, as of August 25, 2010, FDA and the European Medicines have begun working towards a joint effort to streamline pharmaceutical GMP inspections internationally. The goal of this endeavour is to allow more manufacturers to be inspected, while avoiding duplicate inspections.

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