金币
UID176556
帖子
主题
积分25160
注册时间2014-6-6
最后登录1970-1-1
听众
性别保密
|
发表于 2018-10-5 20:30:59
|
显示全部楼层
本帖最后由 beiwei5du 于 2018-10-5 20:32 编辑
变更控制和变更管理
3.3 Change Management System Model
ICH Q10 defnes change management as, “A systematic approach to proposing, evaluating, approving, implementing
and reviewing changes.”
This description makes clear that the scope of change management is broader than the scope of change control,
which is described in ICH Q7 [5], Section 13.
“Change control” often refers to the execution step of an individual change, whereas “change management” is a
more systematic holistic approach to the review and management of a portfolio of changes and the change process,
including all components of “change control.” In an ICH Q10-based PQS change management applies to the entire
product lifecycle. Additionally, if an organization chooses to operate an ISO 9001 system, the change management
system could also include other elements not covered under ICH Q10 or GMP, e.g., changes to business processes
|
|