In Reply to Parent Post by AliceW
If a new cleanroom is built to meet the specs of the old cleanroom and the product has not changed, the process has not changed and the operators have not changed - do you need to re-validate the sterilisation process?
Yes, the relocation involves dismantling and reinstalling ... that calls for a requalification and revalidation.
There was an earlier FDA warning Letter issued to Lydall Inc.
for ETO relocation -
2. Failure to review and evaluate a process and perform revalidations where appropriate when changes or process deviations occur, as required by 21 CFR 820.75 (c). (FDA 483 item #2) Specifically,
a When your manufacturing process was relocated to North Carolina, the Et0 sterilization process was not revalidated. (FDA 483 item # 1.c).