As new regulation deadlines draw nearer, it is important that your business is prepared to meet new regulatory deadlines. The new FDA DQSA and California state pharmaceutical legislation now require pharmaceutical manufacturers and their supply chain units to provide detailed audit trail information and serialize final packaged units of products. Using serialization throughout the manufacturing and distributing processes allows businesses to more effectively trace final products as well as ingredients, helping to ensure the safety of pharmaceutical products.
One of the main functions of the new FDA DQSA regulation is to reduce the supply of counterfeit pharmaceuticals being distributed to consumers. By more closely monitoring raw ingredients and final products using detailed audit trail data based on serial numbers, the chance of these counterfeit drugs reaching consumers can be reduced significantly.
By collecting detailed audit trail data and monitoring it closely, recalls will also be simplified. Using serialization increases product traceability not just by individual product, but by units such as production lines, LOT and SKU. Being able to easily acquire data for multiple measurable units, recalls can be more targeted depending on findings regarding adulterated product.
When using serialization, pharmaceutical manufacturers may also see a reduction in operating costs. Cost savings are typically recognized in reduced chargeback fees and inventory management costs.
To learn more about supply chain serialization or how new regulation may affect your operation, contact Datex experts today at 800.933.2839 x 243 or visit our website www.datexcorp.com