If, during a process chemical validation, one validation batch fails due to an assignable cause, equipment malfunction, how many validation batches are necessary to demonstrate consistency and/or to complete the validation, one more lot or three more consecutive lots?
Q7A Section 12.5 says three consecutive successful batches. When a mechanical or human
error occurs, Q7A allows for judgment in deciding how many additional batches should be run to
show consistency of the process.
