World Health Organ Tech Rep Ser. 2008(948):1-138.
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on the active pharmaceutical ingredient master file procedure; the procedure for assessing the acceptability of male latex condoms and that of intrauterine devices for purchase by United Nations and other agencies; and a review of International Nonproprietary Names for biological and biotechnological substances.
药品制剂规范专家委员会致力于制定清晰、独立且实用的药品质量保证标准和指南。委员会通过全球范围的磋商和国际共识建立过程来制定标准。以下新的标准和指南已获采纳并建议使用:现行可用国际化学参考物质和国际红外参考光谱清单;活性药物成分主文件程序指南;评估男用乳胶避孕套以及宫内节育器供联合国及其他机构采购的可接受性的程序;以及对生物和生物技术物质国际非专利名称的审查。