Reference Standard Management and Qualifications

Using reference standards or materials — substances used as the standard in an assay, identification, or purity test — allows you to assess the impact of any changes to the manufacturing process. One of the primary challenges in reference standard management is ensuring the authenticity and traceability of reference standards, requiring extensive documentation and testing. In addition to meeting regulatory requirements, which can be time-consuming and expensive, they must also be handled and stored appropriately to ensure stability and integrity.

Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity of drug products. Additionally, they equip manufacturers with information they can apply to solve issues and assess the impact of changes to the manufacturing process. By investing in qualified reference standards early in development, Cambrex customers gain an edge in later problem-solving to act swiftly with well-informed decisions.

At Cambrex, we are prepared for these challenges. Our reference standard management program uses a laboratory information management system (LIMS) to create an efficient process for characterizing all reference standards relevant to each manufacturing process. A certificate of analysis (COA) is delivered to our clients with all our qualified reference standards, including detailed reports from the experiments to support regulatory filings. With analytical teams just a few doors down from our process chemists, our facilities are designed to minimize delays caused by the physical separation of different teams. You can rely on our experts’ decades of experience and deep knowledge of regulatory guidelines to deliver high-quality qualified reference standards.