CORE--QUALITY SERVICES

核心——优质服务

• 批准号: 6268637
• 负责人: FRED W HAHN
• 金额: $ 79.8万
• 依托单位: SAINT JOHN'S CANCER INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-24 至 1999-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6268637
• 关键词: behavioral /social science research tag; biomedical facility; health care service; health care service evaluation; neoplasm /cancer

CORE D The proposed projects (I, II, and III) all require the production of injectable substances for treatment diagnosis in human subjects. To ensure that these materials are safe, effective, and pure; an effective quality assurance and quality control program is required by federal regulations and must be instituted. We request personnel and supplies as a core support for the following: 1. Analysis of raw materials, intermediate products, and final products for identity, stability and purity as required by the Good Manufacturing Practices (GMP) sections of the Code of Federal Regulation Analyses include identity verification, sterility, bioburden assessment, endotoxin contamination , mycoplasma contamination, flow cytometry analysis, and potency testing. Review analyses and production records to assess the suitability of each production lot for human clinical trials. 2. Microbiological monitoring of the production facilities to ensure that cleaning, sanitization, and air quality systems are operating effectively. 3. Perform process validation and equipment certification and calibration to ensure that production processes are under control and operate reliable. 4. Provide documentation support, including the writing, reviewing, and control of investigation New Drug Applications (IND), Master and Production Batch Records, Standard Operating Procedures, Specification Analytical Procedures, Labeling, and Validation Reports.

内核D 建议的项目（I、II和III）都需要制作 用于人类受试者治疗诊断的可注射物质。 到 确保这些材料是安全的，有效的，纯净的;有效的 质量保证和质量控制程序是联邦要求的 法规，必须制定。 我们需要人员和补给 为以下方面提供核心支持： 1. 原材料、中间产品和最终产品的分析 按照药品生产质量管理规范的要求进行鉴别、稳定性和纯度检查 《联邦法规分析法》的规范（GMP）部分 包括身份验证、无菌性、生物负载评估、内毒素 污染、支原体污染、流式细胞术分析，以及 效能测试 审查分析和生产记录， 每个生产批次对人体临床试验的适用性。 2. 对生产设施进行微生物监测，以确保 清洁，消毒和空气质量系统有效运行。 3. 执行工艺验证和设备认证及校准 确保生产过程处于受控状态， 可靠 4. 提供文档支持，包括撰写、审核和 新药申请（IND）、主研究和 生产批记录、标准操作规程、质量标准 分析方法、标签和验证报告。