演讲摘要：
将EU GMP Annex 1 与FDA的有关文件进行比较，对EU GMP Annex 1 2003 修改版在日常测试，最小采样量，连续测试，5微米颗粒，5微米的限值以及最新准备进行的修改进行探讨，最后解释了颗粒计数技术如何去适应EU GMP Annex 1的变化。

Compare EU GMP Annex 1 with FDA document, discuss routing test, minimal sample volume, continuous measurement, 5 micron particle and 5 micron limits in EU GMP Annex 1 2003 revision and coming new revision. Explain how particle counting adapts to change of EU GMP Annex 1.

讲演者简介：
顾星成，现任哈希超纯公司电子和制药销售经理，毕业于华东化工学院工业自动化仪表专业，是复旦大学MBA， 曾在福克斯波罗和霍尼韦尔公司工作。

Gu Xingcheng, Electronics & Life Science sales manager of Hach Ultra Analytics, majored in industrial automation instrument and graduated from East China Institute of Chemical Technology and also is MBA of Fudan University, worked for Foxboro and Honeywell before join Hach Ultra Analytics.

E-mail: xingcheng.gu@hach.com