Review of the book “Analytische Qualitätskontrolle und pharmazeutische Mikrobiologie” (Analytical Quality Control and Pharmaceutical Microbiology)
As with some of the previous reviews, this book has also been part of my vacation reading and, in addition to the already hot temperatures, made me sweat a lot ;-)
Therefore, this blog article contains the review of the book "Analytical Quality Control and Pharmaceutical Microbiology", which Concept Heidelberg published in 2015 as part of the Pharma Technology Journal series by Editio Cantor Verlag in the first edition (ISBN: 978-3-87193-424-7).
About the content
The individual chapters of the 198-page book have been written by different authors and outline a wide variety of topics. This encompasses topics such as sampling, its statistical basis as well as microbiological risk assessments. By means of qualification of the laboratory equipment and analytical method validation (or let’s better say: verification of the microbiological analysis methods described in the pharmacopoeia), obtaining reliable results in quality control is ensured. What’s behind these terms and what should be respected in practice is explained in detail. According to ICH Q2(R1), laboratory methods are divided into identification methods, purity and content determinations as well as potency tests. One chapter of this book deals with the application of NIR spectroscopy as an ID method, while another one explains purity determinations and stability studies in more detail. In addition, insights into the preparation of nutrient media and the requirements for hygiene plans are provided. An excursion into the field of change control completes the book.
My impression
Generally, the choice of topics is successful, except for the chapter about change control, which is - in my opinion - a general topic and does not explicitly only concern quality control... Due to the different authors who still work or did work in various pharmaceutical companies and contract laboratories for many years, the topics are examined from different perspectives and with a lot of practical experience. This makes the book very interesting for me. However, depending on the writing style of the different authors, the quality of the individual articles also rises and falls. Some chapters are a bit lengthy and unfortunately overloaded with too many citations and repetitions, while others, on the other hand, are written fluently and clearly and are very understandable due to the examples given. Overall, the content is informative, but unfortunately, partly out of date. Some examples are change control documentation using hand-written forms (instead of electronic systems), citing a guidance document for the hygienic plan already overridden in 2005 or in-house preparation of microbiological culture media (yes, 20 years ago I also poured agar plates myself while nowadays I only know laboratories buying them ready to use...). Didactically, one can emphasize the short summaries at the beginning of each chapter and the good illustrations in many chapters. In addition, further literature supplements each chapter. Some facts could perhaps be presented snappier using a table, some sections could be shortened and the important highlights accentuated by a more appealing presentation, but on the one hand that might be a matter of taste, while on the other hand this is less a textbook than a compilation of practical reports. Accordingly, a missing list of abbreviations cannot really be criticized. However, discovering advertisements in this book made me feel a bit strange...
Last words
In summary, I think the book is well worth reading, but I expected more quality control specific topics. For example, I am missing a few words about specifications, an overview of general drug product / drug substance release testing, handling of non-compliant results (out of specification; OOS), bioassays or the basics of method validation and method transfer... Possibly, this reflects only my personal expectations and my own thirst for knowledge in this area. Nevertheless, I was also able to learn new things, such as testing for specified microorganisms in non-sterile drug products, an area in which I have not yet been active. There are not many German-language books on the subject of pharmaceutical quality control, so this book is definitely suitable for every QC practitioner who wants to get to know a different topic or perspective if he accepts that the book is not up to date. It is also recommended for employees of other departments who like to see something else than their own area and get a first impression of quality control. Thinking about students, a recommendation seems to be ambivalent: On the one hand, you can possibly get an impression of potential future fields of work, on the other hand, the necessary knowledge to understand and assess the presented content might be missing...