A dissolution test as a monitor of batch-to-batch consistency in manufacturing:

The primary purpose of the dissolution test is to distinguish between acceptable and unacceptable batches of a product for human use. However, it is now widely recognized that current practices of dissolution testing may not be used for such purposes, i.e., for bio-relevancy purposes.

Therefore, rather than addressing the underlying deficiencies and improving upon these, the test now commonly propagated as a measure/monitor of batch-to-batch consistency of the manufacturing process. It is not clear which element(s) of manufacturing process(es) the test is linked to and how such a link has been established. In addition, there is a lack of validation of an appropriate link of dissolution to manufacturing. In the absence of such validation, it is not possible to describe this test as performance or quality control/assurance test.

The current practice of dissolution testing as a QC test may be equated to the installation of a sophisticated digital camera to take a picture of every finished car coming out on a assembly line. As long as the pictures are consistence from car-to-car, a car’s performance and quality may be assumed ”assured”. However, as the picture and performance are not linked, there is no guaranty that an acceptable picture in reality will reflect an acceptable performance of the car and vise versa.

Similarly, as a dissolution test is not linked to the performance of a product, acceptable dissolution results may not reflect acceptable performance of the product and vice versa.

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