Ken Appel is the manager of regulated industries for Veriteq.

T

he U.S. Food and Drug Administration (FDA) and its European Union counterparts recently agreed to cooperate on pharmaceutical plant inspections to enable stepped-up enforcement of safety guidelines. These agreements will help regulators be more efficient with their resources, but they also will require every pharmaceutical manufacturer to be on higher alert to maintain a best-practice focus on its quality systems. Mutual agreement among agencies, combined with a focus on risk-based processes, raise the likelihood of more GxP facilities being audited. Now is the time to revisit cost-vs.-benefit analyses for continuous monitoring systems (e.g., wired or wireless networks, and standalone monitoring instruments) that facilitate proof of regulatory compliance.

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