Validation of Dissolution Tester

[Harbani]

Dear All,
Does the dissolution tester needs to be calibrated using tablet callibrator periodically ?
If so, please advice the interval time for the periodic
Thank's

Harbani

[harthur]

I've worked at places that performed the calibration (both physical and chemical tests) on a 6 month basis and at other companies that performed it on an annual basis. Whatever you set up in your SOP's on calibration, you should stick to. You may want to think about your risk assessment when setting up the frequency - how many analyses do you typically perform in a month, 6 months, year? Keeping in mind that if you have a unit that fails calibration, the samples run on that unit since the previous calibration should be looked at for impact.



Dear All,
Does the dissolution tester needs to be calibrated using tablet callibrator periodically ?
If so, please advice the interval time for the periodic
Thank's

Harbani

[johnt]

If you are running in a GMP enviornment it is best to perform complete caibration (Phyical and Chmeical) every six months. Also before a new disoslution system is placed into service an IQ/OQ/PQ should be performed.

[KCBoyz]

For validation Dissolution Apparatus as USP Apparatus 2, do I perform PQ on the Prednisone Tablets as well as on the Salicylic Acid Tablets or only use one USP Reference Std for Apparatus 2, and if so which one?
-Also, on a biannual basis, I do physical parameters (wobble, centering, rpm and height) check as well as using the Prednisone and/or S. A. Tablets?
Thanks

[syx]

Based on Guidance for Industry: Dissolution Testing of Immediate Release Dosage Forms, the apparatus suitability tests should be carried with a performance standard (i.e. calibrators) at least twice a year and after any significant equipment change or movement.
Physical parameters doesn't need to do when the performance test showed good result.

[FARD]

Syx,
u r right that chemical calibration need to be done at least twice a year as per CDER GUDELINES. There is no mention of frequency of physical calibration , but it is preferable to do it on a quarterly basis at least. Also before performing an experiment with basket, it is always prefered to measure the wobble and document it. This would avoid any erroneous results.

[amol]

Every six months, but it depends upon the work load... But minimum for twice in a year...