Guidelines for Pharmacovigilance Product Quality Complaint Handling

1) Purpose

The purpose of this SOP is to outline procedures for handling product quality complaints related to pharmaceutical products.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for product quality complaint handling, including pharmacovigilance managers, quality assurance officers, and customer service representatives.

3) Responsibilities

The Product Quality Complaint Handling Team is responsible for receiving, assessing, documenting, and resolving product quality complaints in compliance with regulatory requirements. The Pharmacovigilance (PV) Manager oversees complaint handling activities to ensure product quality and customer satisfaction.

4) Procedure

4.1 Complaint Receipt and Documentation

1. Receive product quality complaints from consumers, healthcare professionals, distributors, and other sources.
2. Document complaint details, including nature of complaint, product details, and contact information of complainant.
3. Enter complaint data into the pharmacovigilance or quality management system for further assessment.

4.2 Complaint Assessment and Investigation

1. Assess complaints to determine seriousness, impact on patient safety, and regulatory reporting requirements.
2. Initiate investigation into the root cause of the complaint, involving relevant departments such as quality assurance and production.
3. Document investigation findings and decisions.

4.3 Resolution and Follow-up

1. Take appropriate actions to address product quality issues, which may include recall, replacement, or refund.
2. Communicate resolution of complaint to complainant and ensure customer satisfaction.
3. Monitor and document follow-up activities to ensure complaint resolution and prevent recurrence.

4.4 Reporting and Communication

1. Prepare and submit adverse event reports (if applicable) to regulatory authorities as per reporting timelines and requirements.
2. Communicate complaint trends and findings to relevant stakeholders, including quality assurance and regulatory affairs.
3. Ensure accurate and timely reporting of product quality complaints to support regulatory compliance and continuous improvement.

4.5 Quality Control and Continuous Improvement

1. Implement quality control checks to identify systemic issues related to product quality and complaint handling processes.
2. Review complaint handling procedures periodically and update as necessary to enhance effectiveness and efficiency.
3. Participate in training and development activities to enhance complaint handling competencies.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Product quality complaint records, investigation reports, complaint resolution documentation.

7) Reference, if any

EU Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products, FDA Code of Federal Regulations (CFR) Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals.

8) SOP Version

Version 1.0