packaging, delivery, and documentation issues.

3. Responsibilities

• QA Department: Responsible for logging complaints, initiating and conducting investigations, coordinating with relevant departments, maintaining records, and responding to customers.
• Concerned Departments (Production, QC, Engineering, etc.): Assist in the investigation, provide relevant data, samples, and corrective actions.
• Regulatory Affairs (if applicable): Liaise with health authorities where regulatory reporting is required.
• Head – QA: Final review and approval of complaint investigation reports and closure.

4. Accountability

The QA Head is accountable for ensuring all complaints are handled in a timely, thorough, and compliant manner and that investigations lead to effective corrective and preventive actions (CAPA).

5. Procedure

5.1 Receipt and Logging of Complaints

1. All complaints received via email, phone, or in writing must be directed to the QA department.
2. QA shall assign a Complaint Reference Number in the Complaint Register (Annexure-1).
3. The following details shall be recorded:
   • Product name
   • Batch number
   • Nature of complaint
   • Received from
   • Date of receipt
4. An acknowledgment shall be sent to the complainant within 3 working days.

5.2 Classification of Complaints

1. Complaints shall be categorized as:
   • Critical: Complaint indicating risk to patient safety (e.g., contamination, incorrect labeling)
   • Major: Complaint indicating product performance or quality issues
   • Minor: Complaint related to packaging, documentation, or delays
2. Based on classification, the investigation shall be prioritized accordingly.

5.3 Investigation Initiation

1. QA shall initiate a Complaint Investigation Form (Annexure-2) and assign an investigation coordinator.
2. Preliminary assessment includes:
   • Verification of product batch records
   • Review of COA, release results, and in-process controls
   • Checking whether complaint product is within expiry

5.4 Investigation and Root Cause Analysis

1. Cross-functional teams shall evaluate possible causes:
   • Manufacturing or testing deviation
   • Packaging or labeling errors
   • Equipment failure
   • Transportation or storage issues
2. QA shall interview personnel, examine retained samples, and review environmental records if needed.
3. Root cause shall be identified using standard techniques like 5-Why or Fishbone Diagram.

5.5 Corrective and Preventive Actions (CAPA)

1. Based on investigation outcome, suitable CAPA shall be proposed by the relevant department using the CAPA Implementation Form (Annexure-3).
2. All actions must have defined owners and timelines.
3. QA shall track the status in the Complaint CAPA Tracker (Annexure-4).

5.6 Closure and Response to Complainant

1. QA shall prepare a formal Complaint Investigation Report (Annexure-5) summarizing:
   • Complaint description
   • Investigation findings
   • Root cause
   • CAPA taken
   • Conclusion
2. The final response shall be shared with the customer (without disclosing confidential data).
3. Critical complaints must be reported to regulatory agencies as per local regulatory requirements.

5.7 Trending and Annual Review

1. QA shall maintain a Complaint Summary Log and perform quarterly and annual trending analysis (Annexure-6).
2. Repeated complaints or complaints from multiple batches shall trigger deeper investigations or process changes.
3. Trending shall be reviewed in the Management Review Meetings.

6. Abbreviations

• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• COA: Certificate of Analysis
• SOP: Standard Operating Procedure

7. Documents

1. Complaint Register (Annexure-1)
2. Complaint Investigation Form (Annexure-2)
3. CAPA Implementation Form (Annexure-3)
4. Complaint CAPA Tracker (Annexure-4)
5. Complaint Investigation Report (Annexure-5)
6. Complaint Summary Log (Annexure-6)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR 211.198 – Complaint Files
• EU GMP – Chapter 8: Complaints and Product Recall

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 Register

Complaint No.	Product	Batch No.	Date Received	Type	Status
COMP/2025/006	API-A	BATCH123	01/04/2025	Major	Open

Annexure-2: Complaint Investigation Form

Complaint No.	COMP/2025/006
Investigator	Rajesh Kumar
Initial Findings	pH deviation reported
Departments Involved	QC, Production

Annexure-3: CAPA Implementation Form

Observation	Root Cause	Corrective Action	Preventive Action	Owner
pH out of range	Incorrect buffer prep	Buffer discarded, retrained team	Checklist created	Sunita Reddy

Annexure-4: Complaint CAPA Tracker

CAPA No.	Complaint No.	Status	Closure Date
CAPA/2025/011	COMP/2025/006	Closed	10/04/2025

Annexure-5: Complaint Investigation Report

Complaint No.	COMP/2025/006
Summary	pH deviation found during external QC analysis
Root Cause	Human error during buffer preparation
CAPA Taken	Retraining, SOP update, and second-person verification implemented
Status	Closed

Annexure-6: Complaint Summary Log

Month	Total Complaints	Critical	Major	Minor	Repeat
March 2025	4	0	2	2	1

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	Procedure establishment	QA Head
14/04/2025	2.0	Revised with detailed annexures, flow, and classification	GMP compliance	QA Head