树脂的使用期限确定

beiwei5du

In most cases, PPQ will have a higher level of sampling, additional testing, and greater scrutinyof process performance than would be typical of routine commercial production. The level ofmonitoring and testing should be sufficient to confirm uniform product quality throughout thebatch. The increased level of scrutiny, testing, and sampling should continue through the processverification stage as appropriate, to establish levels and frequency of routine sampling andmonitoring for the particular product and process. Considerations for the duration of theheightened sampling and monitoring period could include, but are not limited to, volume ofproduction, process complexity, level of process understanding, and experience with similarproducts and processes.(适当时，PPQ阶段中强化的sampling,additional testing和scrutiny通常会考虑在后期的continued process verification阶段持续，大家是否还是有这方面的考虑呢？？？）

The extent to which some materials, such as column resins or molecular filtration media, can bere-used without adversely affecting product quality can be assessed in relevant laboratorystudies. The usable lifetimes of such materials should be confirmed by an ongoing PPQ protocolduring commercial manufacture. （关于树脂或者分子过滤介质的使用期限的问题，可以用过实验室进行评估确定，并且在持续的onging PPQ(是不是continued process verification阶段）进行确认）


选自FDA 《Process Validation: GeneralPrinciples and Practices 》

beiwei5du

zysx01234 发表于 2016-10-6 12:45
谁还真研究这么深入吗，我看有些厂是对其进行回收清洗后反复用，数量少才补充一点新的，才不会关注用几次。

你说的即是，特别是台州企业（我发现我对台州企业都有偏见了！）

zysx01234

谁还真研究这么深入吗，我看有些厂是对其进行回收清洗后反复用，数量少才补充一点新的，才不会关注用几次。

beiwei5du

We recommend continued monitoring and sampling of process parameters and quality attributesat the level established during the process qualification stage until sufficient data are available togenerate significant variability estimates. These estimates can provide the basis for establishinglevels and frequency of routine sampling and monitoring for the particular product and process.Monitoring can then be adjusted to a statistically appropriate and representative level. Processvariability should be periodically assessed and monitoring adjusted accordingly.


所以一般应该考虑Continued process verification阶段应该还是应该持续PPQ阶段的工艺参数和质量指标的取样监控强度，直到能够采集到足够的数据产生significant variability estimate，然后对后期的常规生产产品或工艺的取样和监控levels and frequency进行确定（即实施相应的periodic testing或skip testing）提供依据。

xqliu

目前还真没有规定使用次数的，整体更换的很少，一般都是补加。