Internal quality control (QC) – what’s that? You routinely perform laboratory analyses, but do you know whether your method also generates permanently reliable results? Yes of course, the method was validated once a long time ago, but since then...? Can you make a statement about the stability of the method? If such questions don't sound entirely unfamiliar, we’d like to introduce a tool today that precisely addresses this issue.

Having already written a blog article about the method validation plan and its contents some time ago and also created corresponding templates, today we’d like to address the question of what the method validation report (to be prepared after execution of the validation experiments) deals with, how it could be structured, and, above all, what makes a good report.

Many analytical methods require calibration to determine the linear range. Linearity tests can be used to check whether the determined calibration function is actually linear.

Depending on the scope / “business area”, checking the linearity using linearity tests is also required for method validations or could at least be useful. In an earlier article, we looked at the relative response in this context.

In the meantime, however, I came across other linearity tests and we will have a look at these in today's article.

Do you manage a QC laboratory in the pharmaceutical industry or a contract laboratory in Germany and are you due for the next inspection by the regional council? Then it may also be worth looking at the Aide mémoire AiM 07123101 "Inspection of analytical validation and method transfer", which was published by the Central Authority of the Federal States (“Länder”) for Health Protection with regard to Medicinal Products and Medical Devices (German: Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) in 2017.

In this blog article, we’d like to give a brief outline of what this ZLG inspection guideline tells us to do in terms of method validation and method transfer.