序号
Q7条
款
英文内容
中文内容
1
1
Introduction
介绍
2
1.3
Scope
范围
3
Has the company designated the point at which the production of the API begins?
是否决定了API生产起点？
4
Can a rationale be provided for this decision?
and/or product defects?
岀现GMP偏离，质量投诉和产品缺陷，如何通知管理层？
24
Average time needed for information?
这种通知平均需要多少时间？
25
2.2
Responsibilities of the QU
QU职责262源自21Are there procedures that ensure that QUreviews and approves all quality related documents?
质量管理
8
2.1
Principles
原则
9
2.11
A Certified Quality Management System (e.g. ISO 9001) is implemented? (if yes, see chapter 20)
质量管理系统是否通过认证（例如ISO9001）?（已通过者参见第20
是否制定了确保QU审核批准与质量有关的所有文件？
27
2.22
Non-transferable responsibilities of QU:
QU直接担负的责任：
28
release/rejection of APIs and IM (to be sold)
IM和API的放行/拒绝
29
establish system to release/reject materials and labels
决定的理由？
5
Has the decision been discussed with the respective authority?
是否与有关药政部门讨论过该决定
6
Are the quality critical steps identified?
是否确认了关键质量步骤
7
2
Quality Management
QA/QC是否独立于生产部门？
15
2.14
Is there an authorized person(s) for the release of IM and APIs?
是否由质量授权人放行IM和API?
16
Who is the person(s)?
谁是质量授权人？
17
2.16
Are all deviations documented and explained?
是否有书面的调查程序？
20
Average days for completion?
平均要调查几天？
21
2.17
How is it ensured that materials are not released or used before completion of evaluation by the QU?
如何保障未经质量部门（QU完成评估的物料不会放行或使用？
22
If not done by QU: Is an appropriate system in place?
如何不是由质量部门（QU负责此事。有否其它相应机构？
23
2.18
Howis managementnotified of serious GMPieficiencies,quality related complaints
早）
10
2.12
Is there a quality policy?
有无质量政策？
11
How is it brought to the attention of the employees?
如何在员工中贯彻质量政策？
12
Is there a Quality Manual or equivalent documentation that describes in detail how the Quality System is implemented?
是否有质量手册一类的文件来详细说明如何贯彻运作质量体系？
13
How does Management review effectiveness of quality system
管理层如何了解质量体系的效果
14
2.13
Is the Quality Unit (QA/QC) independent of production?
36
approving changes with quality impact
批准涉及质量的变更
37
approving validation documents
批注验证文件
38
ensure complaints are resolved
确保投诉得到处理
39
ensuring calibration system is functioning according to procedure executed
批准质量标准和工艺规程
33
approving all quality related documents
批准所有的有关质量的文件
34
ensuring conduction of internal audits
确保进行自检
35
approving contract manufacturers
批准合同制造商
是否所有偏差都有记录和解释？
18
Are critical deviations investigated in a timely manner?
严重偏差是否及时进行调查？
19
Is there a written procedure for handling investigations (6.53)?
建立物料和标签放行/拒绝的体系
30
review of critical process steps batch records
审核批记录的关键工艺步骤
31
ensure critical deviations are investigated
确保严重的偏离得到调查
32
approving specifications and master instructions