Respected All,
Happy Diwali to all of you.
My question is, what is the procedure to follow for equipment requalification?
Below are some reason for planing to start requalification.
so, what is the doc. procedur for the same and what doc. to be prepare for requalification. (i.e, OQ,PQ).
equipment requalification- should be done with respect to your company revalidation periodic planner or any major change.
For error in document errata can be filed.
For REIQ-Verification and calibration status shall done
REOQ-Basic functionality can be again checked.
İn previous equipment qualification, some data were not properly qualified hence again qualification should be carried out through new change control procedure.
Raise CCF through documentation people,
QA will asses the impact of the change weather it’s recommended or not,
once approval from QA, ESD people will do the activity,
afetr compltion of the work,they(ESD DOCUMNT.) will prepare a protocol regarding equipment make,cap.motor type,all the details of equipment. in that protocol each individual department acivities are present like,
ESD part(including Electrical department) for IQ(Intsallation Qualification),
Production part for OQ(Operational Qualification) -Equipment full capacity test,pressur and vacuum tests,utility tests…etc
after completion of all activities which mentioned in the protocol that has to submitt to QA, after review the protocol they(QA)will close the CCF and issues Equipment log book to utilize the equipment in batch execution.
First step will be how it comes to in picture that Data was wrong.
You need to filled the Deviation, you need to do the Investigation as within 4 year numbers of batches were processed on the equipment, you might not know how it was impacting the product quality.
So, Do the Investigation, define CAPA for that, if required any modification in the equipment based on Route Cause Analysis, fill the Change control and move ahead.
Your define CAPA will play major role for the further qualification and equipment which is already qualified.
First you filled deviation because not any change in procedure and machinery so therefor take deviation next to re-qualified the system like OQ, PQ and attached trend data, Stability data for not any major issue with Product that made in 4 years on that equipment also be attach with corrective and preventive action for it.