GMP Environment: Understanding Good Manufacturing Practices

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.

Identification

• 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.

Features

• 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 endeavor is to allow more manufacturers to be inspected, while avoiding duplicate inspections.