RFID and the pharma industry
RFID can increase the safety and visibility of pharmaceutical products — from raw materials, through to manufacturing and
patient consumption — by allowing the tracking and tracing of medications at the item level at each stage of the supply chain,
preventing theft and effectively facilitating management of product recalls to ultimately assure pharmaceutical integrity.
As such, the FDA has recommended the use of RFID tags to better integrate and improve the safety of US medical supply chains.3
For the analytical laboratory, managing and tracking high-end and portable equipment and associated documentation is a core
requirement of laboratory management systems. Doing this 'well' with minimal resource and manual intervention and in a compliant
manner is the key to successful application of RFID in the laboratory. Current systems used in pharmaceutical, biotech and
other regulated environments include simple hard copy inventory lists, spreadsheets, barcoding systems and enterprise resource
program (ERP) systems.
Historically, inventory lists were maintained to monitor asset depreciation or as part of various financial or laboratory
management systems. Lack of information or incorrect information about location, status and usage can, however, cause delays
in laboratory operations or lead to excess inventory of costly assets. Often, information is available, but is stored in different
physical locations, systems or databases. As a result, the ability to defend a laboratory during a regulatory audit can become
difficult. If the integrity of documentation, such as service and maintenance logs, installation qualification (IQ), operational
qualification (OQ) and performance qualification (PQ) records is compromised, then regulated laboratories are under risk of
noncompliance. If documents pertaining to maintenance, qualification and change management are stored in one compliant database,
defence of the laboratory becomes much easier from a holistic perspective.
Integration of RFID technology with compliant database architecture represents a significant step forward in managing laboratory
assets "well", and in a compliant manner.
Features of an RFID-based asset management solution include:
- Real-time management of individual assets or groups of assets.
- Location of assets, locally, regionally or globally.
- Provision of current instrument status including service history.
- Retention of the history of an asset and audit trail of the asset's lifecycle.
- Tamper alert messaging for unauthorised movement of assets that would void equipment qualification in a regulated environment.
- Monitoring of laboratory temperature and humidity with audit trail and alerting mechanism.
- A web-based enterprise system that provides total laboratory asset management.
The benefits of an RFID system compared with traditional barcode and ERP asset management systems are summarised in Table 1.
Table 1: Benefits of an RFID-based asset management system compared with traditional barcode and ERP systems.