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Good Manufacturing Practice is part and parcel of quality management. It ensures that products are always produced and inspected in accordance with the established quality norms for the intended application, as well as the terms and conditions of the marketing authorisation.

The principles of GMP have their basis in European legislation, namely Commission Directive 2003/94/EC (‘Laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use’). Proper storage and distribution is also part of quality management and ensures that quality is maintained at the level prescribed by the marketing authorisation or product specifications throughout the distribution chain (Commission Directive 94/C 63/03).

See also