Thin Layer Chromatography (TLC) and densitometric methods have been used for analysis of various compounds. However, these methods are not used for the analysis of clobetasol propionate (CP) as active ingredient of drugs. CP is frequently used worldwide as pharmaceutical formulation in the form of ointments, creams, lotion, and cosmetics.
Today, we'd like to deal with the question of what is meant by method qualification and clearly distinguish between the two terms method qualification and method validation.
Since laboratory equipment is used when performing analytical methods in the quality control laboratories of pharmaceutical companies or contract laboratories, it must be demonstrably suitable and may not, for example, be used "just like that" (i.e. without prior verification) as in the academic environment. Today, we’d like to deal with this demonstrable suitability.
The purpose of Analytical Instrument Qualification (AIQ) is to demonstrate the suitability of the instrument for its intended use. It is not just a single step process, but a collection of different processes in which many documents, the so-called qualification documents, are created. Depending on the device, this process includes not only the basic check of the function(s) of the device but also, for example, safety aspects for the operator. A very good description is provided in the United States Pharmacopoeia (USP) chapter <1058>. Further requirements can also be found, for example, in Annex 15 of the EU GMP Guidelines. AIQ is mainly comprised of 4 categories:
Within the pharmaceutical industry, analytical instruments are used for specific analysis of drug substances (DS) and / or drug products (DP). Calibration can be explained as a process by which the correct performance of an instrument is ensured. It should not be mixed with the system suitability test (SST), which is performed each time the method is done. The performance of an instrument may vary because of multitude of reasons such as fluctuations in the environment or its ageing components.