What Recall System Audits Cover
A recall system is the set of procedures and resources a company uses to remove product from the market when necessary. It is a system that companies hope never to use, but that must be ready when needed.
A GMP audit for recall systems assesses whether procedures are in place, whether responsibilities are defined, whether communication channels are established, and whether the system has been tested. The scope includes procedures, roles, communication, mock recalls, and documentation.
The Regulatory Context
FDA 21 CFR 211.198 and Recall Procedures
The FDA requires written procedures for recalls and for handling complaints.
EU GMP Chapter 8
Chapter 8 of EudraLex Volume 4 covers complaints and product recall.
MHRA and Recall Timeliness
The MHRA requires recalls to be rapid and timely.
PIC/S and WHO
PIC/S Guide PE 009 and WHO GMP guidelines cover recall systems.
What Audits Focus On
Procedures
Recall procedures should be documented. The audit should check that procedures cover all product types and markets.
Roles and Responsibilities
Roles should be defined. The audit should check that responsibilities are assigned and understood.
Communication
Communication channels should be established. The audit should check that contacts are current and that channels are tested.
Mock Recalls
Mock recalls should be performed. The audit should check that mock recalls are conducted at defined intervals and that results are evaluated.
Documentation
Recall records should be complete. The audit should check that documentation is contemporaneous and traceable.
Common Findings in Recall System Audits
Procedures That Are Incomplete
Roles That Are Not Defined
Contacts That Are Not Current
Mock Recalls That Are Not Performed
Documentation Gaps
Introducing GxP Cellators for Recall System Audits
GxP Cellators provides GMP audits for recall systems covering procedures, roles, communication, mock recalls, and documentation.
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.
Be Ready to Respond
Visit https://www.gxpcellators.com/gmp-auditing/ for service details. Email or use https://www.gxpcellators.com/contact/ to discuss your recall system audit.
Frequently Asked Questions About Recall System Audits
What is a recall?
A recall is the removal of a product from the market because of a quality or safety issue.
How often should mock recalls be performed?
At defined intervals, typically annually.
What should recall procedures include?
Procedures should cover identification, notification, retrieval, and documentation.
Can you help us prepare for an inspection of recall systems?
Yes. We conduct readiness reviews and mock inspections.
How do I request a recall system audit?
Email or use https://www.gxpcellators.com/contact/. Service details are at https://www.gxpcellators.com/gmp-auditing/.
