|
|
Dissolution equipment for testing must be qualified in accordance with GMP. This requires the one-off Installation Qualification (IQ) for the initial assembly or for a change in location of the equipment. Following on from that is the Operational Qualification, the inspection of the equipment properties and compliance with the corresponding specifications. In the case of automatic systems, the OQ means an increased level of effort, because the dosage accuracy and the qualification of measurement sensors also need to be taken into account. Finally, the system needs to be monitored for correct equipment functionality under operating conditions, the so-called Performance Qualification (PQ). Here the dissolution equipment will go through mechanical testing and adherence to the temperature and rotational speed will be monitored. For monitoring purposes, calibrator tablets in accordance with USP (prednisone tablets) will be used. The usage of these USP calibrator tablets has been the subject of controversial debate as the release from these tablets is subject to a high level of variability and to external influences. As a result, the FDA issued a plan in October 2007 for the purely mechanical calibration of dissolution equipment. Requalification of the devices must be performed every six months and this is therefore an extremely cost-intensive part of dissolution testing.
|
