藥典討論小組的協(xié)調活動

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

藥典討論小組的協(xié)調活動

有關活性成分或輔料、制劑或者其他用于藥品制造或復合的物質，藥典各論提供了它們的名稱、定義、性狀，有時候還有包裝、標簽和貯藏說明。之后，各論介紹了構成執(zhí)浦準的實驗、程序和可接受標準。為了排版方便，對于頻繁引用的程序’各論則要參考通則。藥典討論小組的工作就是協(xié)調輔料各論和通則。這將減少生產(chǎn)廠家采用不同可接受標準，用不同方法操作分析程序的負擔。藥典討論小組由來自歐洲藥典、日本藥局方和美國藥典的代表構成，世界衛(wèi)生組織也派代表作為觀察員，他們協(xié)調藥典輔料各論與通則。藥典討論小組的工作始終就是維持最理想的科學水平

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