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The production of medicines must be based on guidelines and Good Manufacturing Practices (GMP, Eudralex, Volume 4) in order to meet the quality requirements and in accordance with the national regulations in force.

Pharmaceutical production is characterized by the obligation to put in place systems whose aim is to reduce to the minimum the risk of defects. Several reasons justify this objective of maximum quality for pharmaceutical products:

  • Manufacturing operations are carried out by production operators and therefore subject to error ;
  • The patient cannot assess the quality of the product ;
  • Potential adverse effects may be significant.

The quality of a product is generated by five elements: Labour (personnel), Materials, Machinery (installations, equipment), Methods (procedures), Environment (working environment).

Chercheur1Examples of Production activities:
  • Construction of premises, study, purchase and installing of new machines, their qualification and validation, programs and methods,
  • Planning, manufacturing and packaging of products,
  • Drafting of procedures and staff training ,
  • Operations planning and management of production staff,
  • Trend analysis