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.   ..read more

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 ..read more

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 ..read more

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 ..read more

Introduction and Background The group of vascular endothelial growth factors (VEGF) plays a crucial role in the formation of new blood vessels (angiogenesis), since they stimulate the growth, i.e. the division and migration of endothelial cells, as the name already suggests. Since some tumor types can better supply themselves with nutrients via increased angiogenesis and thus grow faster, anti-VEGF antibodies represent significant cancer therapeutics. However, the various types of cancer are not the only indication; enhanced angiogenesis is also important in certain eye diseases. Anti-VEGF an ..read more

Today it is once again about the clarification of terms. I recently came across a wide variety of sensitivities, which we will explain today in their respective contexts. Where do they come from and why do they cause confusion ..read more

If you ever wondered why the limit of detection (LOD) is actually calculated using the formula LOD = 3.3 x standard deviation / slopecalibration curve and where the 3.3 actually comes from, this article may shed some light on the subject ..read more

The various techniques of Raman spectroscopy find a wide range of applications in the different areas of the pharmaceutical industry, be it for the detection of counterfeits, as an in-process control (IPC) during the production of the active pharmaceutical ingredient, for content determinations, as an ID test for vaccines, for the simultaneous determination of several product quality attributes (PQAs) as part of a rapid release strategy, up to sterility tests, to name just a few examples [1-4 ..read more

In lyophilizates of pharmaceutical drugs, the residual moisture content must be determined. It must be as low as possible in order to delay possible degradation reactions during storage and thus ensure the declared shelf life. Such a water determination can be performed applying the Karl Fischer titration. This titration method is a widely used procedure for quantitative water determination in a variety of samples and was developed by Karl Fischer in 1935. In the European Pharmacopoeia (Ph. Eur.), chapter 2.5.12 covers the volumetric (semi-micro) determination and chapter 2.5.32 covers the co ..read more

It seems I somehow might say: “No vacation without any technical book!”... Therefore, today's review is about the book “Validation in analytics” by Stavros Kromidas (2nd edition published by the Wiley-VCH Verlag GmbH & Co. KGaA Weinheim in 2011, ISBN: 978-3-527-32939-7 ..read more