Before using any tester, it is commonly understood and often in fact is a requirement to establish that the tester is capable of measuring the expected parameter or characteristics. For our purpose, prior to its use, the apparatus or tester must be shown that it is capable of providing appropriate dissolution characteristics (i.e., percent drug dissolution at times) of a pharmaceutical product. There are different ways of saying the same thing, for example:
The tester is capable of measuring the dissolution characteristics with the required precision; the tester is fit for its intended purpose, or the tester is qualified and validated for its intended purpose.
The usual practice for establishing the “fit-for-purpose” or performance of a tester would be to determine dissolution characteristics of a reference product with its associated precision. If the tester provides the dissolution value with required precision, the tester will be considered qualified and validated. Read the rest of this entry »