Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes.
GMP cleanrooms and GMP manufacturing environments are designed to diminish the risks inherent to (bio)pharmaceutical production, such as viable and non-viable particulates, as well as cross-contamination.The environment is a core component of a Quality Management System and ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
Applications range from Aseptic Processing, Medical Device Manufacturing, Advanced Therapy Medicinal Products (e.g. Cell and Gene therapy) and many more.
Products governed by GMP guidelines 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 sterile 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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