Guidelines for Pharmacovigilance Inspection Readiness

1) Purpose

The purpose of this SOP is to establish procedures for ensuring pharmacovigilance activities are inspection-ready at all times.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for maintaining inspection readiness, including pharmacovigilance managers, quality assurance officers, and compliance specialists.

3) Responsibilities

The Inspection Readiness Team is responsible for preparing and maintaining pharmacovigilance activities and documentation for regulatory inspections. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and effective inspection readiness.

4) Procedure

4.1 Inspection Planning

1. Monitor regulatory inspection schedules and prepare for upcoming inspections.
2. Formulate an inspection readiness plan outlining roles, responsibilities, and timelines.
3. Allocate resources and establish communication channels for inspection-related activities.

4.2 Documentation Review and Organization

1. Review pharmacovigilance documentation required for inspections, including SOPs, training records, and case files.
2. Ensure documentation is organized, updated, and accessible for inspection purposes.
3. Verify documentation compliance with regulatory requirements and internal standards.

4.3 Pre-Inspection Checks and Mock Inspections

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

4.4 Inspection Day Preparation

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

4.5 During Inspection Activities

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

4.6 Post-Inspection Activities

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

4.7 Training and Communication

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

5) Abbreviations, if any

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

6) Documents, if any

Inspection readiness checklist, mock inspection reports, CAPA logs.

7) Reference, if any

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

8) SOP Version

Version 1.0