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Pharmacovigilance and Medical Affairs
Good Pharmacovigilance Practices (GPVP)
GVP Audit is a necessary activity for manufacturers and marketing holders of any drug, food additives, biologics, and devices. It provides an unbiased opinion of operational performance of the Pharmacovigilance system, measuring, ensuring against Quality Management Systems on its own procedures, regulatory guidelines
GVP Audit ensure the collection of more accurate data on adverse events, allow personnel to assess safety issues more accurately, enable appropriate regulatory actions to increase the safety of drugs and devices and to allow manufacturers to be more transparent and provide more effective communication
GVP Audit system is an independent audit strategy which allows our Auditors to review the Pharmacovigilance System Master File (PSMF), Risk Management (RMP), Periodic Safety Update Reports (PSUR), Safety Exchange Reports (SERs), risk benefit assessment, designing, implementation of risk minimization strategy and its management
Our risk-based audit approach is one that uses techniques to determine the areas of risk, where risk is defined as the probability of an event occurring that will have an impact on the achievement of objectives, taking account of the severity of its outcome and/or likelihood of non-detection by other methods
GVP Audit asses the database used for Pharmacovigilance safety reporting and processing is compliant with the current regulations and our GVP Audit will be in line with the GVP Modules III (Pharmacovigilance Inspections) and Module IV (Pharmacovigilance Audits)