SOP for Handling Complaints Related to Quarantined Raw Materials – V 2.0

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SOP for Handling Complaints Related to Quarantined Raw Materials – V 2.0

Standard Operating Procedure for Handling Complaints Related to Quarantined Raw Materials

Department Quality Assurance / Quality Control / Warehouse
SOP No. SOP/RM/087/2025
Supersedes SOP/RM/087/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for receiving, investigating, and resolving complaints related to quarantined raw materials. The purpose is to ensure that complaints are handled systematically, ensuring product quality, compliance with regulatory requirements, and maintaining Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all complaints related to raw materials stored in quarantine at the facility, including issues regarding quality, labeling, packaging, contamination, and non-conformance to specifications.

3. Responsibilities

  • Quality Assurance (QA): Review and investigate complaints, coordinate with relevant departments, ensure proper documentation, and approve corrective actions.
  • Quality Control (QC): Conduct necessary testing and analysis of quarantined materials as part of the investigation process.
  • Warehouse Personnel: Report any identified issues in quarantined raw materials and provide access to the materials for investigation.

4. Accountability

The QA Manager is accountable for the complaint handling process and ensuring that all complaints are addressed in a timely and

compliant manner. The QC Manager is responsible for the technical evaluation of complaints involving raw material testing.

5. Procedure

5.1 Receipt and Logging of Complaints

  1. Complaint Channels:
    • Complaints can be received from internal departments (QC, production, warehouse) or external sources (vendors, regulatory bodies).
  2. Logging Complaints:
    • All complaints must be logged in the Raw Material Complaint Log (Annexure-1) upon receipt.
    • Include the following details:
      • Date and time of complaint receipt
      • Material name and batch/lot number
      • Nature of complaint (e.g., contamination, mislabeling, damage)
      • Person reporting the complaint
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5.2 Initial Assessment and Quarantine Review

  1. Preliminary Investigation:
    • QA initiates a preliminary investigation within 24 hours of complaint receipt.
    • Review quarantine records and perform a visual inspection of the material.
  2. Hold on Material Release:
    • Immediately place a hold on any pending release of the affected material until the investigation is complete.

5.3 Detailed Investigation Process

  1. Sample Testing:
    • QC performs additional sampling and testing of the material, if required.
    • Document results in the Complaint Investigation Testing Log (Annexure-2).
  2. Root Cause Analysis:
    • Conduct root cause analysis to determine the origin of the issue:
      • Supplier-related issues (e.g., material defect)
      • Transportation issues (e.g., damage during shipment)
      • Warehouse handling issues (e.g., improper storage conditions)
    • Document findings in the Root Cause Analysis Report (Annexure-3).

5.4 Corrective and Preventive Actions (CAPA)

  1. Corrective Actions:
    • Implement immediate corrective actions to address the identified issue (e.g., material re-testing, re-labeling, isolation).
    • Document actions in the Corrective Action Log (Annexure-4).
  2. Preventive Measures:
    • Identify preventive measures to avoid recurrence of the issue (e.g., supplier audits, process improvements).
    • Document preventive actions in the Preventive Action Log (Annexure-5).

5.5 Communication and Documentation

  1. Internal Communication:
    • Inform relevant departments (warehouse, QC, production) of the complaint outcome and any actions taken.
  2. External Communication:
    • Communicate with suppliers or regulatory bodies if the issue involves external parties.
    • Document all communication in the Complaint Correspondence Log (Annexure-6).
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5.6 Closure of Complaint

  1. Final Review:
    • QA reviews all documentation and ensures corrective and preventive actions are completed.
    • Close the complaint and document closure details in the Complaint Closure Log (Annexure-7).

5.7 Handling Recurrent Complaints

  1. Trend Analysis:
    • QA conducts periodic trend analysis to identify recurrent issues related to quarantined raw materials.
    • Document findings in the Complaint Trend Analysis Report (Annexure-8).
  2. Escalation Process:
    • Escalate recurring complaints to senior management for further action, such as vendor disqualification or process redesign.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • CAPA: Corrective and Preventive Actions

7. Documents

  1. Raw Material Complaint Log (Annexure-1)
  2. Complaint Investigation Testing Log (Annexure-2)
  3. Root Cause Analysis Report (Annexure-3)
  4. Corrective Action Log (Annexure-4)
  5. Preventive Action Log (Annexure-5)
  6. Complaint Correspondence Log (Annexure-6)
  7. Complaint Closure Log (Annexure-7)
  8. Complaint Trend Analysis Report (Annexure-8)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q10 – Pharmaceutical Quality System
  • WHO Guidelines for Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Complaint Log

Date Material Name Batch Number Nature of Complaint Reported By
01/02/2025 API-X API-X-2025-001 Contamination Detected Ravi Kumar
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Annexure-2: Complaint Investigation Testing Log

Date Material Name Batch Number Test Conducted Result Tested By
02/02/2025 API-X API-X-2025-001 Microbial Testing Positive Sunita Sharma

Annexure-3: Root Cause Analysis Report

Date Material Name Batch Number Root Cause Analyzed By
03/02/2025 API-X API-X-2025-001 Supplier Process Issue Ajay Singh

Annexure-4: Corrective Action Log

Date Material Name Batch Number Corrective Action Taken Implemented By
04/02/2025 API-X API-X-2025-001 Re-tested and Isolated Contaminated Batch Ravi Kumar

Annexure-5: Preventive Action Log

Date Material Name Batch Number Preventive Action Taken Implemented By
05/02/2025 API-X API-X-2025-001 Supplier Audit Scheduled Anjali Mehta

Annexure-6: Complaint Correspondence Log

Date Material Name Batch Number Correspondence With Summary of Communication
06/02/2025 API-X API-X-2025-001 Supplier X Notification of Contamination and Request for CAPA

Annexure-7: Complaint Closure Log

Date Material Name Batch Number Complaint Resolution Closed By
07/02/2025 API-X API-X-2025-001 Batch Rejected, Supplier Investigation Complete QA Manager

Annexure-8: Complaint Trend Analysis Report

Date Material Name Number of Complaints Trend Analysis Findings Recommendations
10/02/2025 API-X 3 in Last 6 Months Recurring Contamination Issues from Supplier X Consider Alternative Supplier

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Updated Complaint Handling and Documentation Procedures Regulatory Compliance QA Head
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