ISPE Publications - Process Validation

ISPE has just released a new process validation discussion paper:  Determining the Number of Process Performance Qualification Batches Using Statistical Tools. The purpose of this paper is to present four statistical tools that may be applied to determine the number of PPQ batches. It presents answers to answer these questions:

  • How many process performance qualification batches (Process Validation Stage 2) are needed to demonstrate a high degree of assurance in the manufacturing process?
  • Is the control strategy is sufficiently robust to support commercial release of the product?

ISPE’s new Process Validation paper is a supplement to our original discussion paper on Stage 2 Process Validation. You’ll learn through simulated examples about statistical approaches and their limitations.

ISPE has received and incorporated considerable input for this paper, and we would love to hear more of your suggestions. The author team is interested in hearing about other possible approaches, and lessons/tips from those who have used the approaches described in the paper. Please send your suggestions to The paper may be modified or expanded in the future to reflect your feedback.

Download the discussion paper today to expand your Process Validation Knowledge. Available to ISPE members only.  Not a member?  Join today to get access to this discussion paper and many other member benefits.