What is a Pharmacovigilance Inspection?

It eliminates the possibility of regulatory findings It demonstrates internal assurance and may reduce inspection risk, but it does not replace an independent inspection It allows the organisation to refuse a regulatory inspection It means regulators will review only the audit schedule

Verbal explanations are prohibited during inspections Objective evidence demonstrates whether processes were actually implemented and controlled Inspectors are required to review only electronic records Records are used mainly to assess the organisation’s financial performance

CAPA implementation, notification, audit, approval, follow-up Notification, preparation, inspection, findings, CAPAs, follow-up Preparation, product approval, inspection, signal detection, notification Inspection, notification, findings, preparation, audit, CAPAs

Disabling system audit trails to improve performance Testing secure remote access, preparing read-only accounts where appropriate and ensuring logs can be retrieved promptly Providing every inspector with unrestricted system administrator rights Moving all records to personal email accounts

To replace the complete PSMF permanently To orient inspectors quickly to governance, products, QPPV contact details and system status To conceal deficiencies identified in the full PSMF To provide a summary of the company’s sales performance

An approved SOP with no associated records A current SOP supported by training records, completed workflow records, quality metrics and evidence of management oversight A draft procedure stored in a shared folder A verbal description from an employee who has not performed the activity

Routine inspection For-cause inspection Pre-authorisation inspection Triggered inspection following a change of QPPV

An inspection is internal, whereas an audit is always conducted by a competent authority An inspection focuses on regulatory oversight and enforcement, whereas an audit supports internal assurance and improvement An inspection evaluates only vendors, whereas an audit evaluates only the QPPV An inspection is voluntary, whereas an audit is legally mandatory in every circumstance

To determine whether the database is the organisation’s most expensive system To assess data integrity, system suitability, controlled changes and access governance To confirm that all users have unrestricted administrative access To replace review of case-processing records

Safety issues, metrics and CAPA progress are regularly reviewed by an appropriate management forum The QPPV is included in safety governance and escalation decisions Significant safety concerns are identified but are not escalated, assigned or tracked to resolution Vendor performance is reviewed against documented responsibilities