What are the GMP Guidelines?

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

Cubic Pharma GMP Cleanroom

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.

Grade A: The local zone for high risk operations
Grade B: For aseptic preparation and filling
Grade C and D: Clean areas for carrying out less critical stages in the manufacture of sterile products.

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

GMP Guidelines