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Home > Medicine & Health Science textbooks > Medical specialties, branches of medicine > Pharmacology > Développement et validation des résidus de médicaments sur les surfaces des équipements
Développement et validation des résidus de médicaments sur les surfaces des équipements

Développement et validation des résidus de médicaments sur les surfaces des équipements


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About the Book

Au cours de la dernière décennie, les processus de nettoyage utilisés dans les opérations pharmaceutiques ont fait l'objet d'une attention croissante de la part des organismes de réglementation et de l'industrie elle-même. À l'heure actuelle, il est généralement considéré qu'il est tout aussi important de disposer de processus de nettoyage efficaces que de processus de fabrication cohérents et validés. Plusieurs développements ont conduit à mettre l'accent sur le processus de nettoyage. Tout d'abord, la nouvelle génération de produits (ainsi que ceux actuellement en cours de développement) tend à être plus puissante (par exemple, beaucoup sont puissants à des doses de l'ordre du milligramme et inférieures). Ensuite, une série de contaminations tragiques se sont produites au cours des dernières années, entraînant des blessures graves. De plus, nous savons que de nombreuses personnes sont sensibles à divers médicaments et que ces sensibilités, souvent décrites comme des allergies, peuvent être très graves. La raison fondamentale pour laquelle il est important de disposer de procédures de nettoyage efficaces et cohérentes est d'éviter la contamination des produits fabriqués ultérieurement dans le même équipement. L'objectif est de fournir à nos patients des produits pharmaceutiques de la plus haute qualité. Il s'agit là d'une exigence réglementaire fondamentale, mais aussi de l'objectif de tous les fournisseurs de produits et de services.


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Product Details
  • ISBN-13: 9786200687432
  • Publisher: Editions Notre Savoir
  • Publisher Imprint: Editions Notre Savoir
  • Height: 229 mm
  • No of Pages: 88
  • Returnable: N
  • Weight: 177 gr
  • ISBN-10: 6200687439
  • Publisher Date: 16 Sep 2025
  • Binding: Paperback
  • Language: French
  • Returnable: N
  • Spine Width: 5 mm
  • Width: 152 mm


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