healthcare professionals, or regulatory authorities.

3. Responsibilities

• QA Department: Receives complaints, coordinates investigations, and ensures timely closure.
• Production Head: Supports technical investigation and implements corrective actions if manufacturing-related.
• QC Department: Performs analytical review or re-testing of retained samples.
• Regulatory Affairs: Notifies regulatory agencies if required.

4. Accountability

Head – Quality Assurance

5. Procedure

5.1 Receipt of Complaint

1. QA shall receive complaints through phone, email, written communication, or online reporting.
2. Log complaint details in the Complaint Register within 24 hours of receipt.
3. Assign a unique Complaint Reference Number (CRN).

5.2 Initial Assessment

1. Determine if the complaint is quality-related, adverse event-related, or logistical.
2. For quality complaints, proceed with a formal investigation.

5.3 Investigation

1. Review batch manufacturing records, in-process control results, and final QC data.
2. Retrieve and analyze retention samples where applicable.
3. Involve cross-functional teams as necessary to trace root cause.

5.4 Categorization of Complaint

• Critical: Product defect with safety risk (e.g., microbial contamination, mislabeling).
• Major: Quality non-conformance affecting performance or stability.
• Minor: Cosmetic or packaging defects with no product impact.

5.5 Corrective and Preventive Action (CAPA)

1. Define appropriate CAPA based on investigation findings.
2. Record CAPA in the CAPA register and link it to the complaint file.
3. Monitor effectiveness of CAPA over a defined timeline.

5.6 Closure and Response

1. Compile investigation findings and CAPA summary.
2. Communicate response to the complainant within 30 working days.
3. Archive complaint file with related batch and CAPA documents.

5.7 Regulatory Reporting

1. If complaint involves adverse event or reportable defect, inform regulatory bodies as per pharmacovigilance norms.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• CRN: Complaint Reference Number

7. Documents

1. Complaint Record Form – Annexure-1
2. CAPA Log Sheet – Annexure-2
3. Complaint Register – Annexure-3

8. References

• WHO TRS 986 Annex 2: GMP Guidelines for Complaints and Product Recalls
• 21 CFR 211.198: Complaint Files (USFDA)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Complaint Record Form

Complaint Reference No.
Date Received
Complainant Details
Product Name
Batch No.
Nature of Complaint
Initial Assessment
Investigation Summary
CAPA Taken
Date of Response
Signature (QA)

Annexure-2: CAPA Log Sheet

CAPA No.	Related Complaint Ref. No.	Action Description	Target Date	Status	Remarks

Annexure-3: Complaint Register Format

CRN	Date	Product	Batch No.	Complaint Type	Status	Closure Date

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
21/09/2022	1.0	Initial issue	New SOP	QA Head
02/06/2025	2.0	Added regulatory reporting section, updated annexures	Annual review	QA Head