Traceability links the physical product to the supplier, documentation, receipt, storage and distribution. A code printed on a vial is useful only when it can be reconciled with genuine records.
Minimum elements
A coherent system retains the supplier identity, shipping documents, receipt date, quantity, batch, monitored conditions, analytical results and the history of release to the customer.
Controlled transparency
Public documents may protect commercially sensitive information, but they should not conceal the elements needed to verify authenticity and the link to the batch.
Method, sources and limitations
This material was written originally and reviewed to distinguish preclinical findings, human studies and commercial status. For legislation and authorisation, consult Directive 2001/83/EC, the EMA and relevant primary scientific literature.
For research use only (RUO). Not for use in humans. This article is not medical or legal advice and provides no instructions for use.