参考标准管理和资格

Using reference standards or materials — substances used as the standard in an assay, 识别, 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, 需要大量的文档和测试. 除了满足法规要求之外, 哪一种既耗时又昂贵, 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 监管 requirements pertaining to purity of drug products. 另外, they equip manufacturers with information they can apply to solve issues and assess the impact of changes to the manufacturing process. 通过在开发早期投资于合格的参考标准, 国家授权正规彩票平台 customers gain an edge in later problem-solving to act swiftly with well-informed decisions.

在国家授权正规彩票平台，我们已经为这些挑战做好了准备. 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 监管 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 监管 guidelines to deliver high-quality qualified reference standards.