It is no secret that regulatory agencies have stepped up their game regarding GVP inspections. The recent pandemic has helped regulatory agencies to become more proficient at virtual inspections, which has increased their capacity for performing GVP inspections. As a result, GVP inspections have increased, and the agencies are expanding their focus; for example, more CROs are now in the crosshairs of these regulatory agencies.

This increased vigilance and constantly evolving regulatory policies have increased the risks for CROs, Generic, and Small Pharma. A bad inspection can have severe consequences, including reputational damage, product recalls, fines, and legal action.

Companies prioritizing pharmacovigilance inspection preparedness can identify and address issues before they become costly problems. This approach helps ensure patient safety, positive inspection outcomes, and the avoidance of CAPAs…Which no one wants as they can be resource-consuming and stressful for management and employees.

Preparation for GVP inspections requires a team of qualified and experienced professionals overseeing your PV systems, processes, and documentation. Regular reviews, for example, conducting mock inspections, and updating these systems and processes, are critical elements of inspection readiness and compliance.

Investing in GVP inspection preparedness is crucial for CROs, Generic, and Small Pharma to maintain compliance with evolving regulatory standards, protect patients, manage reputation, and avoid costly legal and financial consequences.