ISO Guide 34 and ISO/IEC 17025 and the Value of Traceability

In the pharmaceutical industry, the traceability of prescription drugs is increasingly vital to the integrity of these products. By providing end-to-end visibility into supply chains, companies can better trace serialized products from wholesalers to end customers, enhancing reliability while also offering a way to detect counterfeit drugs and track diverted products.

Beyond the supply chain, nearly every functional area within the pharmaceutical facility is now beginning to emphasize traceability. This includes cleaning validation studies and water quality monitoring, where thorough traceability requirements help ensure the accuracy, performance, and reliability of critical total organic carbon (TOC) measurements. The TOC instruments used for these measurements have become a widespread best practice throughout the industry, providing a simple, yet effective way to ensure that processes are in control.

Sievers standards, vials and instruments offer pharmaceutical companies full visibility and traceability. Standards are now accredited under ISO Guide 34 and ISO/IEC 17025, the highest combined accreditation in the industry, while Sievers offers TOC Analyzers with instrument health reporting capabilities and industry experts who prepare Failure Analysis Reports. This offering of complete traceability helps pharmaceutical companies efficiently ‘close the loop’ on TOC out-of-specifications, reducing risks, increasing data quality, and ensuring a reliable and accurate total TOC measurement solution.