LOT-RELEASE TEST VALIDATION STRATEGIES FOR BIOLOGICS

在疫苗批量放行中使用的测试需要验证。验证参数根据测试的性质及其应用而有所不同。该项目的目标是制定适当的策略，以验证可应用于OVRR产品实验室和部门正在开发的分析以及必须在DVP质量控制部门建立的测试的测试。这个项目的一个有用的结果是验证策略在FDA的新测试开发中的实际应用，以及与其他监管机构和行业的合作。另一个成果是制定了适用于分配给生物制品许可申请和补充的监管审查员的测定验证原则。第三个结果是在CBER科学家的主要研究活动中纳入适当的验证程序。这三个成果都已实现，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.