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Industry is Exploring How to Empower Pharmacovigilance Programs to Find GMP Root Causes

Dec 17th, 2013

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Building a system capable of finding quality problems through a firm’s pharmacovigilance program must begin early in development, one of the leading experts in the field, Lilly Global Patient Safety Senior Director John Ayres, is advising industry.

Ayres, an MD and an attorney, discussed the current state of the art in establishing the “GMP links to pharmacovigilence” at a meeting of the PDA interest group (IG) focused on the topic, held in conjunction with the PDA/FDA conference in Washington, D.C. in September.  He is serving as the pharmacovigilance (PhV) IG lead.

“Your strategy very early on should be to establish the pharmacovigilence systems in such a way that you can pick up events of interest,” which are actually due to the product itself rather than “background” noise or other extrinsic factors, and understand the potential connections they may have to quality problems at either the manufacturing or supply chain level, Ayres commented.

He stressed the importance of development, CMC, and manufacturing working together through the product lifecycle to integrate safety and quality information with complaint and stability data to be better able to detect and even predict problems.

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