World Health Organ Tech Rep Ser. 1996;863:1-194.
This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities, the report discusses activities related to the further development of The international pharmacopoeia, as well as simple test methodology, the stability of dosage forms, good manufacturing practices, legal and administrative aspects of the functioning of national drug regulatory authorities, and quality assurance in the supply system. The report is complemented by numerous annexes, including guidelines for the graphic representation of chemical formulae, lists of available International Chemical Reference Substances and International Infrared Reference Spectra, general recommendations for the preparation and use of infrared spectra in pharmaceutical analysis, and guidelines on stability testing of pharmaceutical products. In the context of good manufacturing practices, guidance is provided on the validation of manufacturing processes and for the manufacture both of investigational products for clinical trials and of herbal medicinal products. The final annexes contain guidelines adopted or endorsed by the Committee on registration requirements to establish the interchangeability of multisource pharmaceutical products, implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, the assessment of herbal medicines, and import procedures for pharmaceutical products.
本报告介绍了世界卫生组织召集的一个国际专家小组的建议，该小组旨在审议与药品质量保证以及原料药和剂型规范相关的事项。该报告对药品监管当局尤为重要，它讨论了与《国际药典》进一步发展相关的活动，以及简单的测试方法、剂型的稳定性、良好生产规范、国家药品监管当局运作的法律和行政方面，以及供应系统中的质量保证。该报告还附有大量附录，包括化学式图形表示指南、现有国际化学参考物质和国际红外参考光谱列表、药品分析中红外光谱制备和使用的一般建议，以及药品稳定性测试指南。在良好生产规范方面，提供了关于生产工艺验证的指导，以及关于临床试验用研究产品和草药产品生产的指导。最后的附录包含注册要求委员会通过或认可的指南，以确定多源药品的互换性、实施世界卫生组织国际药品质量认证计划、草药评估以及药品进口程序。
