A snapshot of Serialization in Pharmaceutical Industry.
by Danilo Neri, PQE Group VP Operations & Partner
Most of the regulated agencies have established serialization and aggregation in order to fight counterfeiting and to enhance the level of control of the entire supply chain related to pharmaceutical Products.
Serialization plus Track and Trace to fight counterfeiting of pharmaceutical products.
In order to meet these requirements, several systems are required to be implemented to improve the capabilities of each packaging line, to collect the aggregated serialized numbers and to transmit these data to the relevant regulatory authority.
Track & Trace Domains: a single entity to harmonize the whole implementation.
The implementation process of these systems is usually complex since it is expected to impact a number of different departments, spanning from the engineering department (usually owning the packaging lines) and the IT organization, which are responsible for the implementation of SW application (e.g. Central Repository).
PQE recommends to consider these systems as single entity, termed track & trace (T&T) Domain, to manage the installation of the different components based upon a common and harmonized approach: accordingly the T&T Domain is considered as composed of Computer system, applications, and equipment functionality, along with any related data and information, which is used to govern the Track and Trace End to End Processes.
Validating systems & Risk-Based testing, to ensure Data Integrity and Compliance.
The Validation process shall be based upon predetermined Requirements for each system included in the Domain and these requirements are properly addressing the process constraints and the regulatory expectations.
The reliability of these interconnected systems shall be verified through risk based testing oriented to ensure the integrity of Serialization & aggregation data across the Supply Chain and that the chain of events is documented.
Change-ready design is the key.
The Track & Trace domain is prone to be changes as from the day it is released since new packaging lines might be added or new market including serialization and aggregation requirements might be required to be supplied. Therefore, the System documentation shall be designed to be change-ready in order to optimize the resulting effort.