How Do You Handle Product Complaints Under GMP

How Do You Handle Product Complaints Under GMP?

In a GMP-compliant system, product complaints are not just customer service issues—they’re signals of potential failures in quality, hygiene, or process control. The way you handle product complaints under GMP can make or break your compliance, your brand, and your audit readiness.

Why Complaint Handling Is Critical for GMP

• Protects consumer health and safety

• Identifies root causes of quality issues

• Helps prevent recurrence and costly recalls

• Demonstrates regulatory compliance

• Builds transparency and trust with clients and auditors

Steps to Handle Product Complaints Under GMP

1. Establish a Formal Complaint Handling Procedure

• Create a written SOP for complaint intake, investigation, and closure

• Assign clear responsibilities to QA, Production, and Customer Service

• Ensure procedures are aligned with ISO 22000 or FSSC 22000 if applicable

2. Record the Complaint in a Controlled System

• Use a complaint log or digital system for documentation

• Capture essential details: date, product name, batch/lot number, nature of complaint, customer info

• Assign a unique ID for traceability

3. Classify the Complaint Based on Risk

• Categorize complaints as critical, major, or minor

• Prioritize based on impact to safety, legality, or quality

• Apply faster response times for higher-risk complaints

4. Conduct a Root Cause Investigation

• Use tools like 5 Whys, Fishbone (Ishikawa), or CAPA analysis

• Review batch records, production logs, and test results

• Interview staff and inspect affected equipment or materials

• Trace the issue through supply chain if needed

5. Implement Corrective and Preventive Actions (CAPA)

• Correct the immediate issue (e.g., batch segregation or recall if needed)

• Revise SOPs or retrain staff to prevent recurrence

• Adjust inspection, testing, or monitoring points

• Document CAPA clearly with timelines and responsibilities

6. Communicate with the Complainant Professionally

• Acknowledge receipt of the complaint quickly

• Provide updates on the investigation and resolution

• Share findings if appropriate and explain corrective actions

• Offer replacement or compensation where necessary

7. Report and Review Complaints Regularly

• Analyze complaint trends monthly or quarterly

• Identify recurring issues or supplier-related problems

• Use data to drive improvements in production and quality systems

• Present complaint summaries during GMP or management review meetings

Common GMP Mistakes in Complaint Handling

• Ignoring or underreporting minor complaints

• Lack of documentation or missing complaint logs

• Investigations done without cross-functional input

• Closing complaints without verified corrective actions

• Not linking complaints with non-conformance records

CAYS Scientific Supports GMP-Compliant Complaint Handling
At CAYS Scientific, we help businesses:
✅ Develop effective product complaint procedures
✅ Train staff in root cause analysis and CAPA under GMP
✅ Set up digital complaint tracking systems
✅ Align complaint handling with ISO 22000 and FSSC 22000 standards

📞 Contact CAYS Scientific today to turn your complaint process into a GMP strength, not a risk.