Guidelines for Pharmacovigilance Audit Preparation

1) Purpose

The purpose of this SOP is to outline procedures for preparing pharmacovigilance activities and documentation for internal and external audits.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in audit preparation, including pharmacovigilance managers, quality assurance officers, and compliance specialists.

3) Responsibilities

The Audit Preparation Team is responsible for organizing and preparing pharmacovigilance activities and documentation for audits. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and effective audit readiness.

4) Procedure

4.1 Audit Planning

1. Identify upcoming audits and their scope (e.g., internal audits, regulatory inspections).
2. Formulate an audit preparation plan outlining roles, responsibilities, and timelines.
3. Allocate resources and establish communication channels for audit-related activities.

4.2 Documentation Compilation

1. Compile pharmacovigilance documentation required for audits, including SOPs, training records, and case files.
2. Ensure documentation is organized, updated, and accessible for audit purposes.
3. Review documentation for completeness and accuracy.

4.3 Pre-Audit Checks and Mock Audits

1. Conduct pre-audit checks to assess readiness and identify potential gaps.
2. Perform mock audits to simulate audit scenarios and evaluate preparedness.
3. Address findings and implement corrective actions based on pre-audit assessments.

4.4 Audit Day Preparation

1. Coordinate logistics for the audit day, including scheduling, room setup, and access to required documentation.
2. Assign roles and responsibilities for escorting auditors, providing information, and facilitating audit activities.
3. Prepare for on-site and remote audit scenarios as applicable.

4.5 During Audit Activities

1. Facilitate audit activities and provide requested documentation promptly.
2. Clarify questions and address concerns raised by auditors in a timely manner.
3. Document interactions and findings during the audit process.

4.6 Post-Audit Activities

1. Compile audit findings, observations, and recommendations.
2. Develop and implement corrective and preventive actions (CAPAs) based on audit outcomes.
3. Review and update audit preparation procedures based on lessons learned.

4.7 Training and Communication

1. Provide training to pharmacovigilance staff on audit preparation procedures and expectations.
2. Communicate audit outcomes and lessons learned to relevant stakeholders.
3. Facilitate continuous improvement in audit readiness and compliance.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, CAPA – Corrective and Preventive Action

6) Documents, if any

Audit preparation checklist, mock audit reports, CAPA logs.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module III.

8) SOP Version

Version 1.0