Do QC reagents used in the release testing of drug product lot have to be GMP grade? Can research-grade QC reagents support late-stage drug product testing?
QC批放行测试的试剂是否必须符合GMP标准？研究级别的QC试剂能否支持后期药物产品测试？
DR. SCHULTZ:
Thanks, Steven. Controlling the QC lab is just as important as controlling the manufacturing space. In this case, the reagents that are used in quality control testing should be well-controlled and fit for their purpose. This means that they should be qualified for use prior to your incorporation into the QC lab operation. In general, assay controls should be increased as you progress through the different phases of your clinical development. To support this, you may determine that higher-quality reagents are needed to support consistent assay performance or the in-house qualification of reagents are sufficient to support assay performance.
谢谢，Steven。对QC实验室的控制和对生产区域的控制同样重要。在这种情况下，用于质量控制测试的试剂应该经过良好的控制，并适合其目的。这意味着在将其用于QC实验室操作之前，应是合格的。一般而言，随着临床开发的不同阶段的进行，需要增加检测控制。为了支持这一点，你可能会确定需要更高质量的试剂来保证一致的测定性能，或者内部试剂的资质评定足以支持测定性能。
The controls may be incorporated on many levels to support the consistent and successful quality control testing. For instance, you can incorporate system suitability controls that confirm the consistent assay performance with each run, and this can help to make sure that your reagents are functioning properly.
可以在多个层面上进行控制，以支持一致且成功的质量控制测试。例如，你可以引入系统适用性控制，以确认每次运行时测定的一致性，从而确保试剂的正常功能。
Furthermore, as we move into assay validations, you should include robustness studies to understand how perturbations in the normal assay methods impact assay performance. And while robustness should touch on a number of different points within your assay control and the different parameters in which your assay can function — but it’s really important that these robustness studies also evaluate the impact of different reagent lots and how that may affect your assay performance. Thanks.
此外，随着进行方法验证，您应包括耐用性研究，以了解正常测定方法的扰动对测定性能的影响。而耐用性应涉及检测控制的许多不同点和可能的不同检测参数，但耐用性研究也需要评估不同试剂批次的影响，以及其可能对测定性能的影响。谢谢。