Guidelines for Pharmacovigilance Inspection Management

1) Purpose

The purpose of this SOP is to outline procedures for managing pharmacovigilance inspections conducted by regulatory authorities to ensure compliance with applicable regulations and guidelines.

2) Scope

This SOP applies to the Pharmacovigilance (PV) department and relevant stakeholders involved in preparing for and managing pharmacovigilance inspections.

3) Responsibilities

The Pharmacovigilance (PV) Manager is responsible for overseeing inspection readiness and coordinating inspection activities. All PV personnel are responsible for adhering to this SOP.

4) Procedure

4.1 Inspection Preparation

1. Identify regulatory authorities that may conduct pharmacovigilance inspections, including local health authorities, FDA, EMA, and other relevant agencies.
2. Establish an Inspection Readiness Team comprising PV, Quality Assurance (QA), Regulatory Affairs (RA), and other functional areas to coordinate preparation activities.

4.2 Pre-Inspection Activities

1. Review and update pharmacovigilance procedures, including SOPs, work instructions, and guidelines, to ensure alignment with current regulatory requirements.
2. Conduct mock inspections and internal audits to assess compliance readiness and identify potential gaps or areas for improvement.

4.3 Inspection Notification and Coordination

1. Receive notification of pharmacovigilance inspection from regulatory authorities and promptly inform relevant stakeholders within the organization.
2. Coordinate logistics for the inspection, including scheduling dates, preparing meeting rooms, and arranging accommodations for inspectors.

4.4 Inspection Conduct

1. Host regulatory inspectors and facilitate their access to requested documents, records, and facilities during the inspection period.
2. Assign designated personnel as inspection escorts to accompany inspectors during facility tours and document reviews.

4.5 Response to Inspection Findings

1. Collaborate with cross-functional teams to develop responses to inspection observations and findings within specified timelines.
2. Address corrective and preventive actions (CAPAs) identified during the inspection and implement necessary improvements to ensure compliance.

4.6 Post-Inspection Activities

1. Compile inspection documentation, including inspection reports, responses to findings, and CAPA implementation plans.
2. Conduct internal debriefing sessions to discuss lessons learned, identify opportunities for process enhancement, and reinforce compliance culture.

4.7 Continuous Improvement

1. Review and update Pharmacovigilance Inspection Management SOP based on inspection outcomes, regulatory feedback, and industry best practices.
2. Implement enhancements to inspection readiness strategies and procedures to maintain a state of continuous inspection readiness.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, FDA – Food and Drug Administration, EMA – European Medicines Agency, CAPA – Corrective and Preventive Action

6) Documents, if any

Inspection readiness checklist, mock inspection reports, inspection response templates, CAPA plans.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP) Module III – Pharmacovigilance Inspections.

8) SOP Version

Version 1.0