Most important recommendations for obtaining Good Pharmacovigilance Practices certification in Peru

– Pharmacovigilance audit activities should verify, based on the examination of objective
evidence, that the pharmacovigilance system is adequate, effective, and complies with
the criteria established in national regulations. For a successful audit, it is
recommended to:
– Have an email and phone number dedicated to the pharmacovigilance department of
the establishment.
– Inform DIGEMID about the Pharmacovigilance Officer (FV) and the pharmaceutical
establishment through the e-Reporting system.
– Keep Standard Operating Procedures (SOPs) and pharmacovigilance documents up to
date.
– Establish a self-inspection/general audit program in Pharmacovigilance (FV) or when a
deficiency or need for corrective action is detected.
– Follow up on preventive or corrective actions resulting from a non-conformity.
– Adhere to annual programs according to the established schedule (training, literature
searches, Periodic Safety Reports (PSRs), etc.).
– Follow the guidelines of the Good Pharmacovigilance Practices Inspection Guide
described in R.M. N°1053-2020/MINSA.