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Pharmaceuticals / Postmarket Safety

Quality Expert Asks FDA to Mandate Pharmacovigilance Audits

June 24, 2015

The FDA should implement a pharmacovigilance audit program for drugmakers like the one the EMA adopted in 2012, to reduce the risk of postmarketing adverse events, a quality expert says.

While such audits aren’t required in the U.S., Module IV of the European Medicines Agency’s good pharmacovigilance practices guideline requires drugmakers to perform regular risk-based audits of their pharmacovigilance and quality systems, Michael Baptist, former senior quality assurance associate at Alkermes Pharmaceuticals, told a session of DIA’s annual meeting in Washington, D.C.

Companies in the EU must designate a pharmacovigilance point person to receive the audit results and provide feedback to the auditors on the risk assessment and any planned corrective and preventive actions, Baptist explained.

Any critical or major audit findings related to the system are noted in a pharmacovigilance system master file, along with any proposed CAPAs. Once the CAPAs have been implemented, the note may be removed from the file.

Drugmakers also maintain a list of all scheduled and completed audits, with results and follow-ups documented. — Kellen Owings