I would request the readers to guide me in doing iq oq pq of dissolution apparatus .
thanks
k.manivannan
[quote=Manivannan]I would request the readers to guide me in doing iq oq pq of dissolution apparatus .
thanks
k.manivannan[/quote]
Dear Manivanan
In Installation qualification should include identification and verification
of all system elements, parts, services, controls, gauges and other components, Requirements for calibration, maintenance and cleaning should be drawn up during installation.Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol.Measuring, control and indicating devices should be calibrated
against appropriate national or international standards, which are traceable.
In Operational qualification Critical operating parameters should be identified. Studies on the critical variables should include conditions encompassing upper and lower operating limits and circumstances. Operational qualification should include verifi cation of operation of all system elements, parts, services, controls, gauges and other components. There should be documented records for the verification of operation (operational qualification report) to indicate the satisfactory operation.
In PQ, Systems and equipment should consistently perform in accordance with
design specifications. The performance should be verified in accordance
with a performance qualification protocol. Using disintegrating (Prednisone
and non disintegrating (Salicylic Acid tablets) and challenge the instrument for suitable for dissolution experiments with drug products if the percent of drug released at 30 minutes from the calibrators fall with in are qualify. It is important to note that these values represent the percent of drug release for individual vessels and not the averages, even though the dissolution devices are often equipped with six or 12 vessels and run simultaneously. For a vessel
to be used for product dissolution testing it must, individually, provide acceptable drug release from the calibrator. this test is also the part of dissolution apparatus calibration. but it should be done at the time of PQ, to determine and check the response of equipment.