that all customer complaints are thoroughly investigated, documented, and resolved, and that all relevant regulatory requirements are met.

5. Procedure

5.1 Complaint Receipt

1. Customer complaints may be received through various channels, including customer service, sales teams, or directly from customers.
2. All complaints should be documented in a complaint log (Annexure-1) with the following details:
   • Customer name and contact information
   • Product name and batch number
   • Description of the complaint
   • Date and time of receipt
3. Acknowledge receipt of the complaint to the customer within 48 hours and provide an estimated timeline for resolution.

5.2 Initial Review and Categorization

1. The QA team performs an initial review of the complaint to determine its severity and whether it involves an immediate risk to consumer health and safety.
2. Complaints are categorized into the following:
   • Minor Issues: Issues that do not affect product safety or efficacy.
   • Serious Issues: Issues that may affect the product’s safety, efficacy, or compliance with regulatory standards.
   • Adverse Events: Reports of potential side effects or harm caused by the product.
3. If a complaint involves an adverse event, immediately escalate it to the Regulatory Affairs team for appropriate reporting to regulatory authorities.

5.3 Investigation and Root Cause Analysis

1. For serious or minor issues, the QA team will initiate an investigation into the root cause of the complaint, reviewing relevant records such as batch records, production logs, and environmental conditions during manufacturing (Annexure-2).
2. For adverse events, conduct an investigation into the potential relationship between the product and the reported issue, including a review of the customer’s medical history, product usage, and potential side effects.
3. Interview relevant personnel (e.g., production team, packaging team) and gather any data or information that may explain the cause of the complaint.
4. For packaging-related complaints, inspect packaging processes, materials, and labeling to ensure compliance with specifications.

5.4 Corrective and Preventive Actions (CAPA)

1. Based on the investigation, the QA team will determine appropriate corrective actions to address the identified issue, such as modifying the production process, improving training, or implementing better packaging controls (Annexure-3).
2. If the complaint is related to a product defect, a recall may be initiated, and the affected batch should be quarantined and analyzed further.
3. Preventive actions should be implemented to prevent recurrence, such as updating standard operating procedures (SOPs), conducting additional employee training, or improving quality control measures.
4. All CAPA actions must be documented, and their effectiveness should be evaluated during subsequent audits or testing.

5.5 Communication with the Customer

1. Once the investigation is complete and corrective actions have been implemented, inform the customer of the findings and the steps taken to resolve the issue. This should be done in writing, either via email or letter.
2. Offer compensation or replacements as necessary, depending on the nature of the complaint and company policy.
3. Ensure that all customer communications are polite, professional, and provide a clear explanation of the resolution.

5.6 Documentation and Reporting

1. Document all complaint-related activities, including the complaint receipt, investigation process, CAPA actions, and final resolution in the complaint log (Annexure-4).
2. For adverse events, ensure that all necessary reports are filed with the appropriate regulatory authorities within the required timeframes.
3. Ensure that all documentation is stored securely and is accessible for future reference, including during audits or regulatory inspections.

6. Abbreviations

• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• OOS: Out of Specification
• QA: Quality Assurance
• QC: Quality Control
• FDA: Food and Drug Administration

7. Documents

1. Complaint Log (Annexure-1)
2. Investigation Report (Annexure-2)
3. Corrective and Preventive Action Plan (Annexure-3)
4. Complaint Documentation (Annexure-4)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Complaint Log

Complaint ID	Customer Name	Product Name	Batch Number	Complaint Description	Received Date	Action Taken
CMP-12345	John Doe	Tablet A	Batch 12345	Hardness issue	01/02/2026	Replaced product, process review

Annexure-2: Investigation Report

Batch Number	Test Parameter	OOS Result	Investigation Findings	Corrective Action Taken
Batch-12345	Tablet Hardness	Below specification	Manufacturing error	Process adjustment and retraining

Annexure-3: Corrective and Preventive Action Plan

Action ID	Non-Conformity	Corrective Action	Preventive Action	Completion Date
CAPA-001	Tablet hardness variation	Process reviewed and optimized	New training program implemented	01/04/2026

Annexure-4: Complaint Documentation

Complaint ID	Resolution Status	Communication with Customer	Resolution Date
CMP-12345	Resolved	Replaced product, feedback provided	15/02/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated complaint handling procedures	Clarified customer communication and documentation	QA Head