What Serialization and Traceability Audits Cover
Serialization is the process of assigning a unique identifier to each saleable unit of product. Traceability is the ability to follow that unit through the supply chain. Together they support product authentication, recall, and anti counterfeiting.
A GMP audit for serialization and traceability assesses whether serialization is implemented correctly, whether data is exchanged accurately, and whether traceability is maintained. The scope includes coding, aggregation, data exchange, and documentation.
The Regulatory Context
EU Falsified Medicines Directive
The EU Falsified Medicines Directive requires serialization of prescription medicines and verification at the point of dispensing.
US Drug Supply Chain Security Act
The US DSCSA requires serialization and traceability of prescription drugs through the supply chain.
Other Markets
Many other markets have serialization requirements, including Brazil, China, India, and Saudi Arabia.
PIC/S and WHO
PIC/S Guide PE 009 and WHO GMP guidelines cover serialization as part of the broader GMP framework.
What Audits Focus On
Coding
Codes should be applied correctly. The audit should check that coding is validated.
Aggregation
Aggregation should be performed. The audit should check that aggregation is accurate.
Data Exchange
Data should be exchanged accurately. The audit should check that data exchange is validated.
Documentation
Records should be complete. The audit should check that documentation is available.
Common Findings in Serialization Audits
Coding That Is Not Validated
Aggregation Errors
Data Exchange Errors
Documentation Gaps
Introducing GxP Cellators for Serialization and Traceability Audits
GxP Cellators provides GMP audits for serialization and traceability covering coding, aggregation, data exchange, 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.
Meet Global Requirements
Visit https://www.gxpcellators.com/gmp-auditing/ for service details. Email or use https://www.gxpcellators.com/contact/ to discuss your serialization audit.
Frequently Asked Questions About Serialization Audits
What is serialization?
Serialization is the assignment of a unique identifier to each saleable unit of product.
What is aggregation?
Aggregation is the process of linking individual units to cases and pallets.
How do you validate data exchange?
We review the validation to confirm that data is exchanged accurately and completely.
Can you help us prepare for an inspection of serialization?
Yes. We conduct readiness reviews and mock inspections.
How do I request a serialization audit?
Email or use https://www.gxpcellators.com/contact/. Service details are at https://www.gxpcellators.com/gmp-auditing/.
