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

工藝驗證需要包含多少批？

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.

工藝驗證并不要求具體數量的批次。許多人認為他們必須使用三批來進行工藝驗證，但是這不是必須的。應該著重囊括盡可能多種在商業(yè)生產中可能會發(fā)生的變異源：如不同原料批次、不同供應商、不同操作人員、班次、設備等。這些變異源將決定你工藝驗證的批次。

參考：IVT，F(xiàn)AQ：Statistics in Validation