What Complaint Handling Audits Cover
Complaint handling is the system through which a company receives, investigates, and responds to complaints about its products. It is a critical source of information about product quality and patient safety.
A GMP audit for complaint handling assesses whether complaints are received and recorded, whether they are investigated, whether responses are provided, and whether trends are identified and acted on. The scope includes intake, classification, investigation, response, trending, and CAPA.
The Regulatory Context
FDA 21 CFR 211.198
The FDA requires written procedures for handling complaints and for maintaining complaint files.
EU GMP Chapter 8
Chapter 8 of EudraLex Volume 4 covers complaints and product recall.
ICH Q10
ICH Q10 links complaint handling to continual improvement.
MHRA and Recalls
The MHRA requires recalls to be rapid and timely.
PIC/S and WHO
PIC/S Guide PE 009 and WHO GMP guidelines cover complaint handling.
What Audits Focus On
Intake
Complaints should be received and recorded. The audit should check that intake channels are defined and that records are complete.
Classification
Complaints should be classified by severity. The audit should check that classification is consistent.
Investigation
Complaints should be investigated. The audit should check that investigations reach root cause.
Response
Complainants should receive a response. The audit should check that responses are timely and appropriate.
Trending
Complaints should be trended. The audit should check that trends are identified and acted on.
CAPA
Complaints should lead to CAPA where appropriate. The audit should check that CAPAs are implemented and effective.
Common Findings in Complaint Handling Audits
Intake Records That Are Incomplete
Classification That Is Inconsistent
Investigations That Do Not Reach Root Cause
Responses That Are Not Timely
Trending That Is Not Performed
CAPAs That Are Not Effective
Introducing GxP Cellators for Complaint Handling Audits
GxP Cellators provides GMP audits for complaint handling covering intake, classification, investigation, response, trending, and CAPA.
We work across FDA, EMA, Health Canada, MHRA, WHO, and PIC/S frameworks. Our auditors bring regulatory inspection and industry quality experience, and we deliver clear, prioritized reports with practical remediation guidance.
Listen to the Market
Visit https://www.gxpcellators.com/gmp-auditing/ for service details. Email or use https://www.gxpcellators.com/contact/ to discuss your complaint handling audit.
Frequently Asked Questions About Complaint Handling Audits
What is a complaint?
A complaint is any expression of dissatisfaction about a product or service.
How do you assess investigation depth?
We review investigations to confirm that they reach root cause and that evidence supports the conclusion.
Why is trending important?
Trending identifies patterns that individual complaints may miss.
Can you help us prepare for an inspection of complaint handling?
Yes. We conduct readiness reviews and mock inspections.
How do I request a complaint handling audit?
Email or use https://www.gxpcellators.com/contact/. Service details are at https://www.gxpcellators.com/gmp-auditing/.
