LOT-RELEASE TEST VALIDATION STRATEGIES FOR BIOLOGICS

疫苗批次放行中使用的测试需要验证。根据测试的性质及其应用，验证参数会有所不同。该项目的目标是制定适当的战略来验证测试，这些测试可以应用于OVRR的产品实验室和部门正在开发的测试，以及必须在DVP的质量控制股建立的测试。该项目的一个有益成果是在FDA和其他监管机构和行业的合作下，将验证策略实际应用于开发新的测试。另一个成果是制定了适用于分配给生物制品许可证申请和补充剂的监管审查员的化验验证原则。第三个结果是将适当的验证程序纳入CBER科学家的初步研究活动。所有这三项成果都已实现，该项目的进一步开发和应用仍在继续。

Validation is required for tests used in lot release of vaccines. Validation parameters differ depending on the nature of the test and its application. The goal of this project is to develop suitable strategies for validating tests that can be applied to assays under development in the product laboratories and divisions in OVRR as well as to tests that must be established in the Quality Control Unit in DVP. A useful outcome of this project is the practical application of validation strategies to the development of new tests at FDA and in collaboration with other regulatory agencies and industry. Another outcome is the formulation of the principles of assay validation suitable for regulatory reviewers assigned to biological product license applications and supplements. A third outcome is the incorporation of appropriate validation procedures in primary research activities of CBER scientists. All three of these outcomes have been achieved, and additional development and application of this project are continuing.