Definition
Production or test batches used to gather objective evidence that a process can consistently achieve required results.
Human Explanation
They provide planned evidence that the process operates correctly and repeatably.
Why it Matters
They form important evidence for Process Validation decisions.
Conceptual Boundary
Validation Batches do not replace continued monitoring during routine production.
Practical Perspective
Their number and scope should be justified by risk, process knowledge, variability and applicable requirements rather than a universal fixed number.