CORE--QUALITY SERVICES

核心——优质服务

• 批准号: 6236025
• 负责人: FRED W HAHN
• 金额: $ 57.2万
• 依托单位: SAINT JOHN'S CANCER INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-18 至 1998-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6236025
• 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.

核心D 拟议项目（I、II 和 III）均要求生产 用于人类受试者治疗诊断的注射物质。 到 确保这些材料安全、有效、纯净；一个有效的 联邦要求的质量保证和质量控制计划 并必须制定法规。 我们要求人员和物资 对以下方面的核心支持： 1、原材料、中间产品、最终产品分析 符合良好制造要求的同一性、稳定性和纯度 联邦法规分析规范的实践 (GMP) 部分 包括身份验证、无菌、生物负载评估、内毒素 污染、支原体污染、流式细胞术分析和 效力测试。 审查分析和生产记录以评估 每个生产批次对人体临床试验的适用性。 2. 生产设施的微生物监测，以确保 清洁、消毒和空气质量系统有效运行。 3. 进行工艺验证和设备认证和校准 确保生产过程处于控制和运行状态 可靠的。 4. 提供文档支持，包括撰写、审核和 新药申请 (IND) 调查控制、硕士和 生产批次记录、标准操作程序、规格 分析程序、标签和验证报告。