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.

  • 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


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