LOT-RELEASE TEST VALIDATION STRATEGIES FOR BIOLOGICS

生物制剂批签发测试验证策略

• 批准号: 6436607
• 负责人: ROLF E TAFFS
• 金额: --
• 依托单位: BUREAU OF HEALTH PLANNING AND RESOURCES DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6436607
• 关键词: analytical method; drug design /synthesis /production; drug quality /standard; method development; vaccine development; vaccines

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.

疫苗批放行中使用的检测需要验证。验证参数因测试性质及其应用而异。本项目的目标是制定适当的策略，用于验证可应用于产品实验室和OVRR部门正在开发的检测以及必须在DVP质量控制部门建立的检测的检测。 该项目的一个有用成果是将验证策略实际应用于FDA新检测的开发，并与其他监管机构和行业合作。另一个成果是制定了适用于生物制品许可证申请和补充申请的监管审查员的测定法验证原则。第三项成果是在生物研究和评价中心科学家的主要研究活动中纳入适当的验证程序。所有这三项成果都已实现，该项目的进一步开发和应用正在继续。