hello frnds
i have a serious problem here in our company…some our old R&D equipments dont have validation documents but they are in running condition…so now we plan to prepare complete documentation. please help me with how to go about that??
If you haven’t and don’t make quality decisions with the R&D equipment, you may not need to calibrate it. This is the case in most places, I would hazard to guess. Some put “Not Calibrated” stickers on the equipment to (help) ensure the equipment is not used for quality purposes.
Now if you have used the equipment to make quality decisions, you have a risk that decisions were made based on incorrect data. If that’s the case, you’ll need to do a risk assessment to determine if subsequent actions need to be taken on distributed product. Generally, you would get the equipment calibrated and get a report as to whether or not it was in calibration when checked. If it happens to be in calibration then your risk is substantially lower. If it’s not in calibration, then you’d have to determine the scope of quality decisions made since the last time the equipment was calibrated.
Hope that makes sense.
Well! if ur euipment is in running condition, it shows that the performance of the equipment is in good condition.
So you can take three consecutive trial batches & if the results are as per your specified limits it will serve as a document of PQ for that perticular equipment…Right
Now coming to the IQ; you can’t do it as on date. If i m not wrong the original docs. of the equipment must be missing…
What is there in ur hand as on date is, you can verify the various utilities & based on your actual observations can generate a protocol & report as well for IQ.
Coming to OQ part you can verify the operational limits of that particular equipment ; which can also include ur SOP, the calibrations can be done as on date & it can serve as an doc Of OQ.
[quote=rave04]hello frnds
i have a serious problem here in our company…some our old R&D equipments dont have validation documents but they are in running condition…so now we plan to prepare complete documentation. please help me with how to go about that??[/quote]
thank you both for the suggestions …I hope to start on these suggestions thank you:)
Hi Rave04,
May be thread link will be helpful for you, as the context is similar
Happy Reading !