Dear all,
I am a new employ working in the TS department of a pharmaceutical company.
Our QA officer provided us with a change control for a new balance to be installed in the production plant. This change control defines the following actions for Technical Services Dept. :
IQ/OQ of the balance
Calibration
Maintenance
Could you please help me out (no previous experience).
For the IQ I suspect I should check and find all the components of the balance according to the manufacturer’s manual.
For the OQ what shall I check? And is OQ different from Calibration?
Thank you all very much for your help and congrads for this forum.
I agree with Graham’s assessment, especially the parts about not going overboard and about combining the IQ & OQ in to a single, rather small document. If the balance does conversions, you might want to consider that in the OQ.
One thing to note that happened to a client of ours. They were using a balance just sitting on a table and was frequently moved. They had no procedures in place to verify that the balance was still accurate after a move. The FDA pinged them on this. As a result, they now have the balance on a granite block with a ‘Do Not Move’ sticker on it. Also, they put in their procedures to verify accuracy prior to use. Keep in mind that this is for rather non-critical measurements!
[quote=Cooly]Dear all,
I am a new employ working in the TS department of a pharmaceutical company.
Our QA officer provided us with a change control for a new balance to be installed in the production plant. This change control defines the following actions for Technical Services Dept. :
IQ/OQ of the balance
Calibration
Maintenance
Could you please help me out (no previous experience).
For the IQ I suspect I should check and find all the components of the balance according to the manufacturer’s manual.
For the OQ what shall I check? And is OQ different from Calibration?
Thank you all very much for your help and congrads for this forum.
Cooly[/quote]
Dear Cooly,
I m afaraid that most of the people do forget the PQ during performing qualification of equipments, in addition I do agree with Graham that prefebaly one qualification document should be develop, inwhich IQ, OQ and PQ should be covered.
In PQ, you can check the weights on min and max rated capacity and challenge the rated tolerance.
Thanks
balance is the first and most important equipment in any lab to start the operations… if your weighing is wrong, the complete analysis will be wrong in the lab…
we generally do, iq, oq, pq at customer places…
IQ : Check the appropritate place, environment etc in the lab before keeping the balance… it should be free from aircurrents, should be free from vibrations, temperature should be within the specified limits… etc
OQ : Oparational functionality of the balance, whether it acts as per the design and performing as per the specifications…
we check here, LINEARITY, REPEATABILITY, CORNER ( ECCENTRICITY ) ERROR AND CALIBRATION REPORTS START FROM MINIMUM LEVEL TO THE MAXIMUM LEVEL…
PQ : The performance tests to be conducted at regular intervals fixed by the user and continued…
this is the general procedure we follow in documentation…
I would say that we do the qualifications without realising it eg. you must have placed the balance on a firm, level surface out of the flow of intefering air currents! All you need to do is document this in the IQ as proof that these steps have been followed.
For the OQ/PQ similarly document the relevant steps you followed to ensure that the balance operates as stated in the user manual (according to suppliers specs).
The calibration/ verification may be sufficient to ensure that the balance is performing within spec. Always document all work as proof of it being performed. I like to say that QUALITY IS ORGANISED COMMON SENSE!!!
I would have to say that I agree with madhuv. The balance can be the most important tool that we have in the labs and the IQ/OQ and daily checks are extremely important. That said a URS can be very useful in allowing you to limit the testing regime to suit the purpose of the balance and ensure that it is fit for purpose.
The basic IQ should include checking that the environment is suitable, ensure the equipment is uniquely identified and that all serial numbers are recorded. This should also include confirmation that the balance is the one which you require (suitable minimum resolution etc).
OQ should be adapted around your URS, weighing range, accuracy, printer conformance etc. Depending on the balance you should also record all of the settings within the user variables (can be printed usually be printed off). The testing at this stage is very much dependent on the use so that signed off URS is critical!
The balance is the first stepping stone in a manufacturing process. If you balance is not installed correctly or operating correctly what chance have you or getting a perfectly good product out the door???
I am in the middle of completing a validation of three balances, two are microbalances and one is a top pan balance. I have written one protocol containing an IQ, OQ and PQ, the following is an idea of the level of detail that must be verified;
IQ
Area if installation, what type of surface etc.
Record any configuration parameters/settings
limits (if they will not be changing)
Firmware version
calibration
OQ
Password control verification
balance must be in compliance with URS (checksheet)
functional testing, testing around the limits of the unit (min/max)
USP min weight testing
PQ
Gauge R&R (repeatability and reproducibility) study
I agree that a validation protocol for a balance is way overkill UNLESS it is used during the manufacturing process itself. If it’s being used in production, then yeah, I’d do a full qualification.
Other than that, just look up the USP guidlelines for balance calibration. For our clients, we do USP calibrations annually (some semi-annually) on their balances and that satisfies their needs. USP calibrations will include, as mentioned, eccentricity, corner load tests, cumulative testing, span, etc. Also, the balance manufacturer can provide you the proper weights to use during said testing so that you are in line with their specifications.
I would have to agree with Ruth Cunniffe and DCox.
Some may describe them and “just balances” but if your balance measurements are inaccurate then your whole process, be that lab assay or manufacuring batch, is inaccurate and questionable.
USP has a 0.1% accuracy requirement for analytical balaces and also a requirement for measurement uncertainty to be “not more than” 0.1 from a minimum of 10 replicate weighings. Add this to the fact that USP also requires the minimum weight to be established and you see how seriously they take balance measurements.
It doesn’t have to be a huge amount testing - minimum weight and MU can be calculated from the same replicate set (min 10). Then verify linear accuracy accros the range required from URS with triplicate weighings and eccentricity measurements and corner loading etc. Vendors like Mettler Toledo offer this service.
Moving forward do a daily weight check with 1 weight for trending (as per USP) and monthly performance checks for accuracy - single not triplicate weighings now - and verify MU at minimum weight.
Balances used in manufacture and laboratory testing are critical pieces of equipment - they should be traeted as such.
