Calam D H
National Institute for Biological Standards and Control, Hertfordshire, UK.
J Pharm Biomed Anal. 1995 Dec;14(1-2):1-5. doi: 10.1016/0731-7085(95)01578-7.
As the global market for pharmaceuticals increases, the adverse consequences of different regulations and requirements are becoming more obvious. Discussions between the regulatory authorities for the European Community, United States and Japan under the International Conference on Harmonization (ICH) intended to remove some of these differences are mirrored by similar discussions between the corresponding pharmacopoeial authorities. Moves towards harmonized requirements in pharmacopoeial monographs depend on a consensus view of the purpose and scope of their contents. Aspects of the construction of the four main elements (identification, characterization, control of impurities and assay) of a monograph for an active substance or excipient are considered. The choice of analytical methods is influenced by their availability, the level of control required and their transfer reproducibility between laboratories. Some activities of the Pharmacopoeia Discussion Group, involving the European, United States and Japanese Pharmacopoeias, and their present status are surveyed.
随着全球药品市场的增长，不同法规和要求所带来的不利影响日益明显。欧洲共同体、美国和日本的监管当局在国际协调会议（ICH）下进行的旨在消除其中一些差异的讨论，相应药典当局之间也进行了类似讨论。药典各论中朝着统一要求迈进取决于对其内容目的和范围的共识观点。本文考虑了活性物质或辅料各论中四个主要要素（鉴别、特性表征、杂质控制和含量测定）的构建方面。分析方法的选择受其可用性、所需控制水平以及在不同实验室之间的转移重现性影响。本文调查了药典讨论小组（涉及欧洲、美国和日本药典）的一些活动及其当前状况。
