Audits & Inspections

The form FDA uses to document inspectional observations of conditions that may constitute violations of regulations.

Examination of the electronic record of changes to safety database entries to verify data integrity and identify unauthorized modifications.

FDA's program for inspecting clinical trials, including sponsor oversight of safety reporting, investigator compliance, and IRB operations.

The ongoing effort to enhance pharmacovigilance processes, systems, and outcomes through systematic evaluation and implementation of improvements.

A severe inspection observation indicating that pharmacovigilance processes fundamentally failed to ensure patient safety or regulatory compliance.

A formal request from inspectors for specific documents, records, or data during a pharmacovigilance inspection.

A regulatory inspection triggered by specific concerns, such as safety issues, compliance complaints, or signals of potential violations.

Adherence to Good Pharmacovigilance Practice as defined in EU guidance modules covering all aspects of pharmacovigilance operations.

The final meeting at the end of an inspection where preliminary findings are discussed and next steps are outlined.

An observation of non-compliance or deficiency identified during a regulatory inspection, categorized by severity (critical, major, minor).

The state of preparedness to undergo a regulatory inspection at any time, including organized documentation, trained staff, and current processes.

The formal written reply to an inspection report, addressing each finding with root cause analysis, corrective actions, and preventive measures.

A systematic, independent examination of pharmacovigilance activities conducted by the company's quality function to ensure compliance and identify improvement opportunities.

An inspection observation indicating significant non-compliance that could potentially affect patient safety or reliability of pharmacovigilance data.

A simulated regulatory inspection conducted internally or by external consultants to assess readiness and identify areas for improvement.

An official examination by a regulatory authority of a company's pharmacovigilance system, processes, and documentation to verify compliance with regulations.

Measures taken by regulatory authorities in response to compliance issues, ranging from warning letters to product withdrawal.

Conversations between inspectors and company personnel to verify understanding of procedures, roles, and responsibilities.

An assessment of third-party service providers performing pharmacovigilance activities to verify capability, compliance, and quality.

An official FDA communication citing significant regulatory violations that must be addressed to avoid further enforcement action.