GMP Guidelines

Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes.

Products must:

• be of consistent high quality
• be appropriate to their intended use

• meet the requirements of the marketing authorisation (MA) or product specification

"Annex 1 - Manufacture of Sterile Medicinal Products" - states the rules governing medicinal products in the European Union.

For the manufacture of sterile medicinal products 4 grades can be distinguished.

Sources: Gov.uk, Annex 1 - Manufacture of Sterile Medicinal Products