Performance qualifications fails on one batch out of 3 batch , what is next action plan
First, you will have to investigate into the matter to find out root cause of failure. Once found, then address the issue and perform process optimization, if necessary. This should be followed by performance qualification on three batches to get consistent results meeting acceptanice criteria. If any major changes are required to be done before repeating performance qualification then it should be routed through Change control.
Find root cause of failure.Make adjustments by trouble shooting if possible or if not then destroy it by WDN.
If trouble shooting is done then make changes of materials, process, parameters in BMR by change control and change revision no of BMR.
Then again perform the performance qualification on 3 batches according to the changes made.
- Raise Deviation as it doesn’t meet the PQ protocol requirement.
- CAPA, RCA