V2EX cgmp

CGMP

释义 Definition

CGMPCurrent Good Manufacturing Practice(s) 的缩写,常译为“现行药品/产品良好生产规范”。指监管机构(如美国 FDA)对药品、医疗器械、食品、保健品等产品在生产、质量控制、记录、人员与厂房设备等方面的强制性要求,用于确保产品安全、有效、质量稳定

发音 Pronunciation (IPA)

/si di m pi/

例句 Examples

The factory must follow CGMP to ensure product quality.
工厂必须遵守 CGMP,以确保产品质量。

After the inspection, the company updated its CGMP documentation, retrained staff, and strengthened process controls to prevent contamination.
检查后,公司更新了 CGMP 文件,重新培训员工,并加强过程控制以防止污染。

词源 Etymology

CGMP 源自监管与工业领域的缩略语:Current(现行的) + Good(良好的) + Manufacturing(制造) + Practice(s)(规范/实践)。其中 Current 强调“随法规与行业标准更新的现行要求”,区别于早期版本的 GMP 表述;在美国法规与 FDA 语境中常用 cGMP/CGMP 指代现行要求体系。

关词 Related Words

文献与作品 Notable Works

  • Code of Federal Regulations 21 CFR Part 210/211(美国药品 CGMP 法规核心文本)
  • ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients(原料药 GMP 国际指南)
  • EudraLex, Volume 4 EU Guidelines for Good Manufacturing Practice(欧盟 GMP 指南)
  • FDA Guidance for Industry(多份行业指南中频繁出现 cGMP/CGMP 用语)
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