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Benchmarking survey of the implementation and impact of QA aspects of the PV System Master File

Module 11 of the EU Guideline on Good Pharmacovigilance Practices (GVP) relating to the pharmacovigilance system master file (PSMF) came into effect on 2 July 2012. RQA had conducted a previous survey which was designed to investigate the perceived impact of the legislation on Audit and Quality groups within the pharmaceutical industry; the results of which were published in the January 2012 edition of Quasar.

A follow-up benchmarking survey was commissioned by the Good Pharmacovigilance Practice Committee and was designed to investigate how companies have implemented the QA aspects of the requirements for the PSMF and what impact this has had on QA activities in general.

A summary of this survey can be found here