Quality Management System
Quality Management System
The objectives of a Quality Management System are to :
Does Pharmaceutical regulation apply in the cloud
Does Pharmaceutical regulation apply in the cloud
"Cloud Computing" awkwardly frenchified in "Informatique dans les nuages" is currently undergoing a major commercial communication; IT managers of pharmaceutical companies are challenged by their top management about this "newness":
Qualifications Plans TQP
Qualifications Plans TQP
  The Test Qualifications Plans (TQP) is one critical step for any pharmaceutical site wishing to obtain GMP conformity. TQP being the last part of building of a production unit, temptation is high to request that TQP team catch up the delay cumulated during the implementation phases. Time...
Quality by Design : Le challenge de l'application des produits biologiques
Quality by Design : Le challenge de l'application des produits biologiques
Quality by Design : Le challenge de l'application des produits biologiques L'approche de Quality by Design (QbD) présentée dans l'ICH Q8(R2) pour le développement du Drug Product est aujourd'hui confortée dans le nouveau guide ICH Q11 qui concerne le développement de la substance ac...
Sterilizing filtration: is there a negative impact on the bioburden related to the use of non aseptic pre-filtration devices?
Sterilizing filtration: is there a negative impact on the bioburden related t...
Our manufacturing processes provide a 0.22 µm pre-filtration step immediately before the sterilizing filtration stage. These two operations are performed in controlled atmosphere zone, grade A.
Microbiology Expert Committee Takes Closer Look at Contamination, Antibiotic Potency and Modern Methods
Microbiology Expert Committee Takes Closer Look at Contamination, Antibiotic ...
For manufacturers, the extent of microbial contamination in a finished product must always be a consideration.
La performance de la filtration tangentielle associée à l'usage unique
La performance de la filtration tangentielle associée à l'usage unique
Qu’il s’agisse d’ultrafiltration ou de microfiltration, la technique du flux tangentiel ou crossflow est utilisée pour limiter le colmatage en surface des membranes.
La revue qualité produit
La revue qualité produit
Le 25 octobre 2005 a été publiée une nouvelle version du chapitre I des BPF Européennes. La nouveauté consiste essentiellement en l'introduction d'un paragraphe sur la Revue Qualité des Produits (Product Quality review PQR)
Quality Management System
Does Pharmaceutical regulation apply in the cloud
Qualifications Plans TQP
Quality by Design : Le challenge de l'application des produits biologiques
Sterilizing filtration: is there a negative impact on the bioburden related to the use of non aseptic pre-filtration devices?
Microbiology Expert Committee Takes Closer Look at Contamination, Antibiotic Potency and Modern Methods
La performance de la filtration tangentielle associée à l'usage unique
La revue qualité produit

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