hi every one
firstly :(I’m not expert in qualification of equipments
and now i try to created re-Qualification protocol for tablet press machine and need help
template( if present)
Thanks
its easy and i think there is no specific methodology to do that, the idea that to prove that the machine is still performing as intended and there is no drift over the time, this can be done by combining OQ with PQ
So,
make re qualification protocol which includes:
1- All OQ tests (All functional tests and challenges)
2- Follow Operating SOP and check that the machine is in compliance with its operating SOP
3- Attach all last calibrating reports
4- attach preventive maintenance SOP + Calibration SOP + Cleaning SOP
5- Collect the last 10 batches (if available) produced on the same machine and record results of testing in your protocol, these tests for batches are the same tests you performed when you performed PQ for the machine (concurrent), so it is like doing retrospective validation for the machine regarding PQ part.
regards
shadi
Shadyahmad has covered the majority of the necassary tests required.
In addition to the 5 item listed, include a basic IQ test sheet that incorperates the checking for any leaks and worn parts (such as hydraulic and air and electrical) as well as an OQ compliance check of all the Change Controls, Deviations, Concessions etc that have been raised with the equipment under test for the period under review(since last review until date of test).
Hope that is of some help.