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Equipment Qualification

Equipment Qualification



|Views: 2,691 |Likes:
Published by swapnil_ballal
Overview on Equipment Qualification in Pharmaceutical Set up
Overview on Equipment Qualification in Pharmaceutical Set up

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Categories:Types, Business/Law
Published by: swapnil_ballal on Dec 16, 2009
Copyright:Attribution Non-commercial


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Equipment Qualification:Regulatory requirement,Business need or CommonSense
Swapnil BallalIntas BiopharmaceuticalsLtd.Nov 09
Dec 16, 2009S.Ballal, Intas Biopharmaceuticals Ltd.2 of 28
FDA Warning Letters relatedto EQ
Inadequate laboratory equipment calibration program: failure to havewritten procedures describing specific calibration instructions and limits .
Failure to conform to the USP section «41» for weight and balancedetermination.
The inspection revealed that erroneous values are being used to performthe minimum weight studies. No certification to a recognized standard for the weights set used for checking the balance.
The calibration procedure for HPLC systems is inadequate in that it did not include integrator and detector’s linearity, injector’s reproducibility, and accuracy of temperature settings for column heater and detector.
There are no predetermined acceptance criteria for the HPLC auto sampler calibration.
Procedures for UV/VIS Spectrophotometer only assesses linearity usingalkaline potassium chromate solution at one wavelength when analytical tests are performed at various wavelengths. The procedures does not include functional tests such as wavelength accuracy, photometric accuracy, and reproducibility within ranges of intended use for theinstrument.
Calibration raw data and results obtained for the performance qualificationof analytical instruments is not being checked for accuracy and completeness by a second analyst or laboratory supervisor.
Dec 16, 2009S.Ballal, Intas Biopharmaceuticals Ltd.3 of 28
So What is EquipmentQualification?
Equipment Qualification is used as anumbrella term covering the steps thatensure an instrument or equipment isappropriate for its intended use.The user has the ultimate responsibility forthe accuracy of results and for thequalification of his/her equipment.

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