26/08/2015 Number of samples in PQ/validation of a fully automated 100% visual inspection system 在全自动100%目视检查系统PQ/验证中的样品数量 As a rule, in the PQ and even more so in the validation, the batch size typical of the future routine production are expected. But does it make sense to compare the detection rates of humans and machines based on complete batches with 20,000 vials, for example? 在PQ或者说甚至是在验证中，作为常规要求，一般是希望能使用将来常规生产的批量。但是，使用人工检出率来与机器检出率来对比，例如，检查一个2W支瓶的完整批量，是不是有意义呢？ In the PQ/ validation of the system, the human-machine comparison is made by repeatedly testing the Qualification Test Sets. This is a product-specific test set that contains the approximately 20% defects that can occur in the real process. The ECA Best Practice Guide recommends a minimum of 10 repetitions of the test. For additional security, parts of a validation batch can be inspected as well, for example, 5000 units. It is also possible to combine samples from the three validation batches for a total of 5000 units. However, this mixes up the batches and afterwards, the inspectetd units may not be returned to their batches if they are intended for the market. 在系统的PQ/验证中，人工与机器的比较是通过重复确认测试序列来实现的。该测试所用的对象是产品测试系统，其中有约20%的缺陷瓶，这是真实工艺可能发生的概率。ECA最佳规范指南建议至少重复10%的测试。为提高保险性，验证批的一部分也可以进行检查，例如，5000个单位包装。也可以将三个验证批的样品合并，获得总共5000个单位包装。但是，如果这些批次是要上市销售的话，这样的混合批以及之后受检的瓶可能不能再返回其原始批号中。 As part of revalidation, the 5000-unit test can be repeated regularly. 作为再验证的一部分，可能要定期进行5000个单元测试。 http://zhuyujiao1972.blog.163.com/blog/static/98694727201572693721723/