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.

If you are working within the pharmaceutical industry or are somehow related to it, you must have come across the terms; Drug Substance, Drug Product, and Excipients. Although simple, many people make obvious mistakes dealing with them. In this short article, we wrote a brief overview about the terms with supporting examples.

In this article, we will write about the life cycle of a drug from discovery to its release with a focus on its development and validation.

Drug discovery and development

Every drug, that is sold in the market starts its journey from being discovered. Researchers spend years to identify the drug substance for a particular target.