药典讨论小组的协调活动
PHARMACOPEIAL DISCUSSION GROUP’S (PDG) HARMONIOUS ACTIVITIES
A pharmacopoeial monograph for an active ingredient or excipient, preparation, or other substance used in the manufacture or compounding of a medicinal product generally provides a name, definition, description, and sometimes packaging, labeling, and storage statements. Thereafter, the monograph provides tests, procedures, and acceptance criteria that constitute the specification. For frequently cited procedures, a monograph may refer to a general chapter for editorial convenience. The Pharmacopoeial Discussion Group (PDG) works to harmonize excipient monographs and general chapters. This will reduce manufacturers' burden of performing analytical procedures in different ways, using different acceptance criteria. The Pharmacopoeial Discussion Group (PDG), which includes representatives from the European, Japanese, and United States pharmacopeias, and WHO (as an observer), harmonizes pharmacopoeial excipient monographs and General Chapters. At all times, the PDG works to maintain an optimal level of science consistent with protection of the public health. 3
药典讨论小组的协调活动
有关活性成分或辅料、制剂或者其他用于药品制造或复合的物质，药典各论提供了它们的名称、定义、性状，有时候还有包装、标签和贮藏说明。之后，各论介绍了构成执浦准的实验、程序和可接受标准。为了排版方便，对于频繁引用的程序’各论则要参考通则。药典讨论小组的工作就是协调辅料各论和通则。这将减少生产厂家采用不同可接受标准，用不同方法操作分析程序的负担。药典讨论小组由来自欧洲药典、日本药局方和美国药典的代表构成，世界卫生组织也派代表作为观察员，他们协调药典辅料各论与通则。药典讨论小组的工作始终就是维持最理想的科学水平
