injectable products manufactured at the facility, including product defects, adverse reactions, and quality-related issues.

3. Responsibilities

• QA Head: Overall responsibility for complaint handling and closure.
• Complaint Handling Officer: Receives, records, investigates, and coordinates all activities related to complaint investigations.
• Production Head: Provides relevant manufacturing information for investigation.
• QC Manager: Conducts sample analysis if required during investigation.

4. Accountability

The Quality Assurance Department is accountable for ensuring that all product complaints are handled, investigated, documented, and closed in a timely and compliant manner.

5. Procedure

5.1 Complaint Receipt and Recording

1. Complaints may be received via telephone, email, written letters, regulatory bodies, or field representatives.
2. Immediately log the complaint in the Product Complaint Register (Annexure-1).
3. Assign a unique complaint ID in the format: COMP/YY/NNN.
4. Acknowledge receipt to the complainant within 2 working days.

5.2 Preliminary Assessment

1. Review complaint description, product details, and batch number.
2. Check if similar complaints have been reported earlier.
3. Evaluate if the complaint is critical (e.g., sterility failure, adverse event, contamination).
4. Inform QA Head immediately if criticality is high.

5.3 Investigation and Root Cause Analysis

1. Form a cross-functional investigation team (QA, QC, Production, Regulatory as needed).
2. Review:
   • Batch Manufacturing Record (BMR)
   • Packaging records
   • In-process control results
   • Environmental monitoring data
3. If sample is returned, send to QC for analysis and retain records in Annexure-2: Sample Analysis Log.
4. Document findings in Annexure-3: Complaint Investigation Report.

5.4 Corrective and Preventive Actions (CAPA)

1. Based on investigation outcome, initiate appropriate CAPA.
2. Assign CAPA responsibilities with target dates.
3. Track CAPA completion and effectiveness verification.

5.5 Closure and Documentation

1. QA Head reviews investigation and CAPA completion.
2. Approve final closure with documented conclusion and corrective measures implemented.
3. Update Complaint Register with closure status and date.
4. Maintain complaint records for a minimum of 5 years.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• BMR: Batch Manufacturing Record

7. Documents

1. Product Complaint Register – Annexure-1
2. Sample Analysis Log – Annexure-2
3. Complaint Investigation Report – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR 211.198 – Complaint Files
• WHO TRS 986 Annex 2 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Product Complaint Register

Complaint ID	Date	Product	Batch No.	Nature of Complaint	Status
COMP/25/001	10/06/2025	Inj. Ceftriaxone 1g	CTJ25001	Particulate matter	Closed

Annexure-2: Sample Analysis Log

Complaint ID	Sample Received	Test Performed	Result	Analyst
COMP/25/001	Yes	Visual Inspection	Particulate Confirmed	Priya Nair

Annexure-3: Complaint Investigation Report

Complaint ID	Investigation Summary	Root Cause	CAPA Taken	Closure Date
COMP/25/001	Packaging fiber found inside vial	Operator error during capping	Retrained staff, added inspection step	15/06/2025

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/07/2022	1.0	Initial Release	New SOP	QA Head
18/06/2025	2.0	Added CAPA traceability and sample log	Review Update	QA Head