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

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).

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

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