VALIDATION OF COMPENDIAL EQUIPMENT OF DISSOLUTION TEST APPARATUS-I.P

Dissolution test apparatus stands one of key requirements of pharmacy academia & research lab in understanding the bioavailability and bioequivalence of prepared and available drug formulations as an estimate for further studies in continuing research. Hence validating this compendia equipment for quality assuring as preapproval inspections is need of the hour for timely appropriateness in using the equipment on regular basis. In this experimental work is detailed with the design, installation, operational and performance & maintenance qualification procedures as provided by the equipment vendor. This process has to be performed from time to time for expedite effectiveness and compliance.

Keywords: design qualification, installation qualification, operational qualification, performance qualification, maintenance qualification, validation.