ICH Q10 制药质量系统（行业指南）

风筝与风

I. 简介(1, 1.1) ................................................................................................................................... 3
II. 只要质量管理体系 ....................................................................................................................... 3
A. 范围 (1.2) ................................................................................................................................. 4
B. ICH Q10与地方GMP要求、ISO标准和ICH Q7之间的相互关系 (1.3) .................................. 5
C. ICH Q10与管制方法的相互联系 (1.4) ........................................................................................ 5
D. ICH Q10的目标(1.5) ..................................................................................................................... 5
E. 助推器：知识管理和质量风险管理 (1.6) .................................................................................... 6
F. 设计和内容 (1.7) ............................................................................................................................ 6
G. 质量手册 (1.8) ............................................................................................................................... 7
III. 管理职责 (2) ............................................................................................................................... 7
A. 管理承诺(2.1) ................................................................................................................................ 7
B. 质量方针 (2.2) ............................................................................................................................... 8
C. 质量策划 (2.3) ............................................................................................................................... 8
D. 资源管理 (2.4) ............................................................................................................................... 8
E. 内部交流 (2.5) ............................................................................................................................... 9
F. 管理审核 (2.6) ............................................................................................................................... 9
G. 外包活动和外包物料的管理 (2.7)................................................................................................ 9
H. 产品所有权变更的管理 (2.8) ....................................................................................................... 9
IV. 工艺性能和产品质量的持续改进(3) ........................................................................................... 9
A. 生命周期各阶段的目标 (3.1) .................................................................................................. 10
B. 制药质量系统元素 (3.2) .......................................................................................................... 10
V. 制药质量系统的持续改进 (4) .................................................................................................... 14
A. 制药质量系统的管理审核 (4.1) .................................................................................................. 14
B. 对影响制药质量体系的内部和外部因素的监控(4.2) ............................................................... 15
C. 管理审核和监控的成果 (4.3) ...................................................................................................... 15
附 录 1 提高科学和风险性法定方法的潜在机会* ....................................................................... 19
附 录 2：ICH Q10制药质量体系模式示意图 ................................................................................ 20

lanchong

美国FDA的“制药质量系统”指南。打开好像有点问题。

waynes

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waynes

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