Review of the book "Qualitätskontrolle von Impfstoffen” (Quality control of vaccines)
After outing myself in the last blog article as a fan of the "essentials" series, I’ve enthusiastically read some more books, but unfortunately haven’t found any time for reviews yet. This should change right now. Therefore, in this blog article I’d like to present the book "Quality Control of Vaccines" by Patric U.B. Vogel, published in 2020 by Springer Spektrum, Wiesbaden (ISBN: 978-3-658-31864-2). Of course, this book has also accompanied me - in keeping with tradition - on a vacation ????
About the content
On slim 49 pages (including literature), this booklet creates a damn good first impression of the different tasks of quality control. After an introduction, specifications, sampling, and the "analytical environment" including qualification and validation are explained to provide the background for the subsequently extremely well described individual release and stability tests of vaccines. Furthermore, the question is addressed what happens in case of OOS results, thus results not meeting the specification. A brief outline of quality deficits and associated vaccine recalls and a crisp summary make the booklet perfect. Structurally, I like the fact that all the quality control tasks mentioned in the introduction are discussed in the subsequent chapters, although retain samples and reference samples might get a raw deal. In addition, the “entry and exit pages” (what I can find and what I can take along) with a few bullet points, which I already praised in the last review, are not missing and simply put it in a nutshell.
Positives and negatives
I like the choice of topics, although the chapter on recalls is very interesting, it basically has nothing to do with quality control. An excursion towards monitoring / trending could have been interspersed, but the interested reader should be told that the author has written a separate booklet about it...
Apart from that, this book, like the one presented before, is written in a very understandable and descriptive way and, moreover, keeps up with the times by referring to Covid-19. [Side note: let’s think in this context about the USP draft for the analytical methods for mRNA vaccines...]. From a didactic point of view, the good illustration should be emphasized on the one hand, and on the other hand, the keywords written in bold make it easy to grasp the content.
It is a great pity that this book, just like "Validation of bioanalytical methods", contains many spelling errors, lacks one reference, the years mentioned in the text do not match to the ones given in the reference section in two cases and that the number of months in the explanation of the determination of shelf life is wrong (which can be seen by the correct one shown in the figure). This would encourage me to ask my lector for a little bit more thoroughness ???? Unfortunately, there are also some slight redundancies in content within the book and it also seems that whole sections from the previous book have been copied word for word… Such a copy & paste is of course only noticeable to readers who have read both books, but then results in a negative connotation and appears to be "cheaply slapped together"... And the book doesn’t really need that. Just as in the predecessor, the terms "qualification", "validation" and "verification" are not clearly distinguished from each other, but are used somehow vaguely, and it is not clear whether sampling is performed by quality control or production personnel. Nevertheless, these small negative features do not have much impact, as otherwise the content is excellent and fully meets my own expectations towards the book. There are very few books in German that deal with quality control of pharmaceuticals and this book is an absolute gleam of hope.
Closing words
For me personally, this book was a look beyond my own nose, because my own activities with viruses didn’t take place in a GMP environment and unfortunately, I haven’t yet come across vaccines in my working life... My particular highlight was the chapter presenting the essential methods of release testing relevant for vaccines. Thinking of a target group for this booklet, I would unreservedly recommend it to all those employed in other departments of pharmaceutical companies, as it provides a very good overview of quality control.