zhulikou431
再谈谈这个问题。
在仪器分析中，日常易耗件更换涉及变更的问题，那么QC部门做过这个变更控制?

随着这个变更控制，就引出一个话题，如果一台分析仪器更换一个部件，例如柱子因柱效降低需要更换、或者因为等能量降低，需要更换灯，需要验证?再验证进行到什么程度，sst足够吗？还是IQOQPQ一起来一遍？

这些问题都要思考。一个符合法规和GMP得分析实验室，绝对应该有一个专门的QA的。
让我们学习一下PIC的指南，下面列出了变更可能引起再验证的情况：（注意e）

6.7.4 Changes that are likely to require Re-validation are as follows:
(a) Changes of raw materials (physical properties such as density,
viscosity, particle size distribution may affect the process or product),
(b) Change of starting material manufacturer,
(c) Changes of packaging material (e.g. substituting plastic for glass),
(d) Changes in the process (e.g. mixing times, drying temperatures),
1 July 2004 Page 17 of 26 PI 006-2
(e) Changes in the equipment (e.g. addition of automatic detection
systems). Changes of equipment which involve the replacement of
equipment on a 'like for like' basis would not normally require a Revalidation,(f) Production area and support system changes (e.g. rearrangement of
areas, new water treatment method),
(g) Transfer of processes to another site,
(h) Unexpected changes (e.g. those observed during self-inspection or
during routine analysis of process trend data).

应该根据自己实验室情况，建立一个like for like清单，这样再更换功能或者性质类似的部件，就不需要做再验证，而是SST足矣。