新建药厂纯化水sop什么时候完成？

whqiang78

新建药厂，纯化水做验证，周期比较长，那么纯化水sop什么时候编写完成，生效执行？

言以足志

sop在设备安装调试完成后即可编写，待质量部批准后即培训到位开始执行

青稞公子

验证之前必须要有SOP

beite12

安装确认之后就要起草SOP草稿了

song_85122

OQ实施前需呀完成相关的操作SOP

准圣级药老

纯化水sop草案在运行确认期间完成，于性能确认第一阶段完成后正式实施。这是在验证指南里有提到过的

0132218

验证前须有sop，验证进行确认，如需要则根据验证的结果进行修订

王瑞刚

这就是个先有鸡还是先有蛋的问题，别太纠结了。

hycwq77

一般先有SOP的草案，待安装运行确认完成后，就可正式批准生效

仁者心动

OQ前完成，OQ结束后批准

绝酷-刀-

SOP在纯化水系统初步安装运行的时候，就由相关工作经验的起草编写，佐以相关图片，图文并茂告知纯化水系统如何操作使用。验证过程中会对该SOP的可行性就行验证，验证完毕就正式出台了。

东北以东

制药初学者 发表于 2017-10-30 08:33
纯化水sop草案在运行确认期间完成，于性能确认第一阶段完成后正式实施。这是在验证指南里有提到过的

这个靠谱，第一阶段就是为了证明SOP的合理性，有问题可以在这个阶段调整，第一阶段结束后生效

beiwei5du

东北以东 发表于 2017-10-30 09:16
这个靠谱，第一阶段就是为了证明SOP的合理性，有问题可以在这个阶段调整，第一阶段结束后生效

那么这段文字你们怎么认为？？选自：https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074905.htm，虽然这对于高纯水，但是纯化水系统原则也一样。
按照这个说明水系统的操作SOP最终稿应该是在PQ的第一阶段完成后制定完成，并且PQ第二阶段是对已完成的SOP的再次确认。那么如此一来SOP的草案应该在OQ完成后制定，相对比较合适。

After all the equipment and piping has been verified as installed correctly and working as specified, the initial phase of the water system validation can begin. During this phase the operational parameters and the cleaning/ sanitization procedures and frequencies will be developed. Sampling should be daily after each step in the purification process and at each point of use for two to four weeks. The sampling procedure for point of use sampling should reflect how the water is to be drawn e.g. if a hose is usually attached the sample should be taken at the end of the hose. If the SOP calls for the line to be flushed before use of the water from that point, then the sample is taken after the flush. At the end of the two to four week time period the firm should have developed its SOPs for operation of the water system.

The second phase of the system validation is to demonstrate that the system will consistently produce the desired water quality when operated in conformance with the SOPs. The sampling is performed as in the initial phase and for the same time period. At the end of this phase the data should demonstrate that the system will consistently produce the desired quality of water.

The third phase of validation is designed to demonstrate that when the water system is operated in accordance with the SOPs over a long period of time it will consistently produce water of the desired quality. Any variations in the quality of the feedwater that could affect the operation and ultimately the water quality will be picked up during this phase of the validation. Sampling is performed according to routine procedures and frequencies. For Water for Injection systems the samples should be taken daily from a minimum of one point of use, with all points of use tested weekly. The validation of the water system is completed when the firm has a full years worth of data

东北以东

beiwei5du 发表于 2017-10-30 09:34
那么这段文字你们怎么认为？？选自：https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074905 ...

不矛盾啊，根据草案进行第一阶段的操作运行，期间有问题调整草案，第一阶段结束后草案生效

医械界小学生

设备安装好，验证时

西文

纯化水sop草案在运行确认期间完成，于性能确认第一阶段完成后正式实施

玄月望夏

你的SOP要在你的设备安装之前就初步定稿，然后随着验证的进行，将原稿中不合理的地方进行修订，这个验证本来就是验证你的SOP的

hongyu

质量部批准后即培训到位开始执行

小强123456

等检查老是来的时候是必须得有的，验证完成前你可能是初版，整个完成后，升级

枫林之秋

从检查角度，运行确认开始之前必须要有sop,可以是草案，运行确认后可以再升级或生效正式版本，安装确认不需要设备操作，不要求必须起草。实际上，很多常规设备，URS确定后就可以起草sop了。