DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS

点击翻译按钮获取中文摘要

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.