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Any manufacturer of medicines intended for the EU market must comply with GMP.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production. The main risks are:
- contamination of products
- incorrect labelling
- insufficient or excessive active ingredient
GMP ensures that every step of production follows strict, documented protocol. The areas of inspection include:
- materials
- premises
- equipment
- training
- personal hygiene of staff
GMP requires that medicines or medical ingredients:
- are of consistently high quality
- are appropriate for their intended use
- meet the requirements of the marketing or clinical trial authorization
Documented systems ensure that correct procedures are consistently followed at each step in the manufacturing process — every time a product is made.
