Qualification Status

Quality Assurance
1

what is qualification status maintenance? I have done equipment qualification.next due date is after 3 years.how i would ensure qualification in this duration?

2

First you should justify the frequency of 3 years for re-qualification of equipment.
During this period you can ensure maintenance of Qualification status through performance checks, Coseley monitoring it’s functioning, Calibration of measuring devices attached to it and finally by doing preventive maintenance of the equipment at defined frequency.

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3

Perform periodic review at defined frequency of each equipment and in that evaluate calibration,maintenance, deviation, change control, market complain and after review and evaluation make a decision that equipment is healthy or not.

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4

Dear Pragnesh,

Suppose there is an old stability chamber and it get offline from regular calibration and revalidation as machine get out of use, and after 2 years, it undergoes some midification and rectification and started working after re-qualification and mapping conducted satisfactorily, meanwhile the Stability chamber missed to be included in calibration schedule and revalidation planner and there was gap of two years was found
How you will handle this matter!!

Thanks

5

Thank you Sir for your kind information. I ll be there with new query next time😊

6

Thank you Sir for your kind information. I ll ask other questions too which I would be un able to find my self

Regards😊

7

Dear Asif,

First of all, what is the reason of “Out of Use”?
If it is out of use, how you have handled the procedure, as per all industry follow the making of calibration and maintenance planner yearly, if it is not performed it is a deviation.
Second is why it undergoes modification and rectification? if it is not used for the 2 years and why it goes under modification and rectification.

It is required to handle through QMS,

So if it is pre planned to be not used for future, you can raise the change control and mentioned the reason and also identified the impacted document as you mentioned calibration planner, maintenance planner and other impacting documents such as validation planner.

If GAP is found after two year, you can raise the deviation, do investigation define proper CAPA and remediate the action through GAP analysis.

I hope, i met your expectation.

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8

Thank you Pragnesh,
The CAPA shall be as Re-Temperature mapping and calibration and revalidation planner update!!?

Also, what if the product was stored during this Gap period,? impact,
only it have records for monitoring BMS trends.

Thanks.

9

No, it is only a part of CA - Corrective action but you need to define Preventive action as well.

Because as a part of investigation, you need to identified why it was missed out for the define activity mentioned in the planner and what are the precautionary measure you are going to take which will ensure that this is not going to happen again.

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10

Right
ok