How many lots or batches do I have to include in my process validation?

工艺验证需要包含多少批？

Process validation does not require a specific number of batches or lots. Many people believe they must use three lots to perform a process validation, but this isn't necessarily adequate. Instead, focus on including as many sources of variation as you expect to encounter in commercial production: multiple raw material batches, multiple suppliers, multiple operators, shifts, equipment, etc. Including these sources of variation will determine the number of lots required for your validation.

工艺验证并不要求具体数量的批次。许多人认为他们必须使用三批来进行工艺验证，但是这不是必须的。应该着重囊括尽可能多种在商业生产中可能会发生的变异源：如不同原料批次、不同供应商、不同操作人员、班次、设备等。这些变异源将决定你工艺验证的批次。

参考：IVT，FAQ：Statistics in Validation