Source: Deutsche Nachrichten
In pharmaceutical wholesale distribution, picking the correct product in the correct quantity is not enough. The batch must also be correct. Two medicine packs that look identical may belong to different manufacturing batches and have different expiry dates. If this information is not recorded correctly during picking, traceability and quality assurance can be compromised.
For pharmaceutical wholesalers in Ireland, batch-controlled order picking is therefore an essential part of warehouse operations compliant with Good Distribution Practice (GDP). A digital Warehouse Management System helps systematically document batch information and reduce errors during order fulfilment.
Why Batch Numbers Are Essential During Order Picking
Batch numbers enable medicinal products to be traced back to a specific manufacturing batch. This information is particularly important when dealing with quality defects or product recalls.
For example, if a particular batch of a medicine is recalled, the wholesaler must be able to determine which quantities remain in stock and which customers have received the affected products.
An item number alone is not sufficient.
The Warehouse Management System must therefore establish a clear connection between the product, batch, quantity and storage location. Complete traceability also requires the corresponding goods receipt and distribution records.
FEFO Instead of FIFO for Medicinal Products
In addition to batch numbers, expiry dates play an important role when selecting stock for picking.
While the FIFO (First In, First Out) principle prioritises products received first, FEFO (First Expired, First Out) prioritises products with the earliest expiry dates.
For example, a warehouse holds two batches of the same medicinal product. Batch A was received in January and expires in December. Batch B arrived in February but expires in September.
Under the FEFO principle, Batch B should generally be picked first, provided no other quality-related requirements take precedence.
A batch-capable Warehouse Management System can support these picking rules. However, this requires accurate batch and expiry date records and appropriately configured warehouse processes.
Recording Batch Information Directly During Picking
Manual batch number documentation is particularly prone to errors when processing high order volumes. Transposed digits, illegible notes and subsequent manual data entry can make traceability more difficult.
The COSYS Warehouse Management System (WMS) supports mobile order picking and the digital documentation of stock movements.
Employees can identify products using barcodes and confirm stock withdrawals directly at the storage location. For batch-controlled processes, it is essential that batch information is maintained within the relevant system configuration and correctly assigned during picking.
GS1 barcodes are particularly useful when they contain the required information. The relevant Application Identifiers can encode details such as product identification, batch number and expiry date.
For mobile data capture, the Datalogic Memor 17 is a suitable example of a compact mobile computer for barcode-based warehouse operations.
COSYS can also provide suitable hardware and services covering device configuration, repairs and replacements.
GDP Requirements and Documented Stock Movements
The EU Good Distribution Practice (GDP) guidelines, applicable to pharmaceutical wholesale distribution in Ireland, establish requirements for quality assurance and traceability. The Health Products Regulatory Authority (HPRA) is the competent Irish authority responsible for overseeing compliance in this area.
Digital warehouse processes can support the documentation required under these regulations. However, compliance depends not only on the software itself but also on its integration into an appropriate pharmaceutical quality system.
Relevant measures include clearly defined user access rights, traceable transactions, controlled correction procedures and risk-based validation of computerised systems.
A Warehouse Management System is therefore not automatically GDP-compliant. Its suitability must be assessed against the specific processes, system configuration and applicable regulatory requirements.
Business Intelligence and Process Mining Improve Transparency
The process data recorded during order picking also creates opportunities for quality and operational analysis.
With COSYS Business Intelligence, pharmaceutical wholesalers can analyse product movements, inventory developments and picking volumes. Where the necessary data is available, inventory can also be analysed by batch and expiry date.
COSYS Process Mining additionally enables businesses to examine actual workflows using digitally recorded process events.
For example, companies can investigate where picking orders remain unprocessed for unusually long periods, where activities are repeated or where delays occur before goods dispatch.
These analyses support continuous process improvement but do not replace mandatory quality controls.
Conclusion: Batch Traceability Begins at the Storage Location
Reliable batch-controlled order picking requires more than recording a product number. Only the correct connection between batch, expiry date, stock movement and delivery provides a traceable product history.
COSYS supports pharmaceutical wholesalers with modular Warehouse Management Software, mobile data capture, suitable hardware, technical services and data-driven analytics. This enables companies to digitalise picking operations and establish a structured foundation for batch documentation.
Tip: Would you like to explore mobile order picking and warehouse processes? Try the COSYS demo apps free of charge and without obligation in the Google Play Store or Apple App Store.