Small book - small review ;-) ?
Well, not exactly...
I'm going to reveal myself now - as a fan of the “essentials” series! Therefore, I‘d like to talk today about the book "Validation of Bioanalytical Methods" by Patric U.B. Vogel, which was published in 2020 by Springer Spektrum, Wiesbaden (ISBN: 978-3-658-31951-9).
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 coulometric titration. The choice of method is primarily based on the amount of water present in the sample.
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).
Some time ago, I received a very interesting request that I’d like to use as an opportunity for writing this blog article.
According to the draft of the revised Annex 1 "Manufacture of Sterile Medicinal Products" of the EU GMP guidelines, sterile filters should be discarded after having been used. Multiple use is excluded, with the exception that a use for more than one working day has been validated. This phrasing is not quite unambiguous. So how should we interpret the following requirement "Liquid sterilizing filters should be discarded after the processing of a single lot. The same filter should not be used for more than one working day unless such use has been validated." (8.89)?