Please discuss re-validation as it relates to scale-up. If the same equipment is used, is there any restriction on how much the scale can be increased prior to re-validation? If similar but different equipment were used, would re-validation be required?

This is not addressed by Q7A, nor does the guidance place any restrictions on scale-up, either
before or after validation. The potential impact of the proposed change on the quality of the
intermediate or API should be evaluated through the company’s change control procedures.