DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS

肠胃外剂型的开发和生产

• 批准号: 2300407
• 负责人: TIMOTHY D SMITH
• 金额: $ 141.24万
• 依托单位: BEN VENUE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-05-01 至 1997-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2300407
• 关键词: DEVELOPMENT; PRODUCTION; PARENTERAL; DOSAGE; FORMS

The contractor shall develop and produce sterile clinical drug supplies of various batch sizes to include freeze dried parenterals, liquid filled parenterals, ampules, and occasionally large volume parenterals intended for human use. The contractor's facilities must be FDA inspected and in compliance with good manufacturing practices and all FDA drug requirements. The contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, facilities, testing, certificates of analysis, and final reports required to support NCI's Investigational New Drug Applications (INDs) files with the Food and Drug Administration (FDA). In addition, the contractor shall provide adequate analytical instrumentation to perform complete quality control of both new drug substances and formulated products. Finally the contractor shall be responsible for packaging, labeling, properly storing, and shipping all products produced by the contract.

承包商应开发和生产无菌临床药物供应 各种批次大小，包括冷冻干燥的注射用液体 注射用，安瓶，有时大容量注射用 供人类使用。承包商的设施必须经过FDA的检查并符合 遵守良好的生产规范和所有FDA药品 要求。承包商应被要求提供所有 必要的服务，合格的人员，材料，设备，设施， 支持所需的测试、分析证书和最终报告 NCI的食品和药物研究新药申请(INDS)文件 药品监督管理局(FDA)。 此外，承包商应提供足够的分析 仪器对这两种新药进行全面的质量控制 物质和配方产品。最后，承包商应 负责包装、贴标签、妥善储存和运输所有产品 按合同规定生产的产品。