指 导 原 则 编 号 ： 【H】 G P H 1 - 1 化 学 药 物 质 量 标 准 建 立 的 规 范 化 过 程 技 术 指 导 原 则 二 ○ ○ 五 年 三 月 目 录 一 、 概 述 ·································································································································1 二 、 质 量 标 准 建 立 的 基 本 过 程 ·······················································································1 （ 一 ） 质 量 研 究 内 容 的 确 定 ····················································································2 （ 二 ） 方 法 学 研 究 ··········································································································3 （ 三 ） 质 量 标 准 项 目 及 限 度 的 确 定 ······································································3 （ 四 ） 质 量 标 准 的 制 订 ·····························································································3 （ 五 ） 质 量 标 准 的 修 订 ·····························································································4 三 、 药 物 的 质 量 研 究 ···········································································...
