The quality System in Good Pharmacovigilance Practices (GVP) Good statistical practices regarding the quality control of lots applied to the cases processing

نویسنده

  • Véronique CHAPALAIN
چکیده

This paper shows that pharmaceutical companies and CRO often fail to respond to the recommendations of Good Pharmacovigilance Practices (GVP) by highlighting the lack of efficiency of the quality control (QC) process applied to the pharmacovigilance cases processing. The paper summarized the sampling acceptance statistical theory behind the good statistical practices regarding QC of lots and show that these principles can be easily implemented to set up an optimized QC system ensuring the quality of safety case processing in Pharmacovigilance units.

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تاریخ انتشار 2014