Fda gmp guidelines pdf

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Unsourced material may be challenged and removed. GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP. A “c” or “C” is sometimes added to the front of the initialism.

The preceding “c” stands for “current. For example, cGMP is an acronym for “current good manufacturing practice”. The term GxP is frequently used to refer in a general way to a collection of quality guidelines.

The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics. Traceability: the ability to reconstruct the development history of a drug or medical device. Accountability: the ability to resolve who has contributed what to the development and when.

Documentation is a critical tool for ensuring GxP adherence. For more information, see good manufacturing practice.