Introduction

Although this time it’s not about pharmaceutical method validation¹, I’d like to take up an interesting question about the upper limit of linearity. We’ve got the following topic: For the performance of real-time polymerase chain reactions (RT-PCR) to detect SARS-CoV-2, the comparability of 2 thermal cyclers should be determined. For this purpose, the Ct values of the two thermal cyclers (let's call them A and B) were plotted against each other at different sample concentrations. 

In today's blog article, we’d like to take a look at sterility testing and its verification. As this is a compendial method, we should talk about verification instead of validation in this context, even though unfortunately we often still read about validation of this method. To stick with the wording, in the pharmacopoeias this is referred to as method suitability test (MST), which in my opinion fits very well 😉 

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.