Blog articles

Risk assessments in method validation

Written by Dr. Janet Thode on . Posted in Method validation

Risk assessments are a good thing and can make life easier in the pharmaceutical environment. Everywhere it is said that this or that has to be or has been defined "risk-based"...

Hmm, all well and good, but where are the potential applications in the validation of analytical methods?

We’d like to make a deep dive into this question in today's blog post.

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Review of the book “Validierung bioanalytischer Methoden" (Validation of bioanalytical methods)

Written by Dr. Janet Thode on . Posted in Think out of the box

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).

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Verification of a compendial method: Water Determination by Karl Fischer Titration

Written by Dr. Janet Thode on . Posted in Method validation

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.

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Multiple use of sterile filters?

Written by Dr. Janet Thode on . Posted in Filter validation


Some time ago, I received a very interesting request that I’d like to use as an opportunity for writing this blog article.


The question

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)?

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Influence of polysorbate 20 on the filter integrity test of a PVDF sterile filter

Written by Gastautor on . Posted in Filter validation

As part of the release testing of parenteral pharmaceuticals, sterility of the pharmaceuticals must be ensured after filling. Since a direct check of every filled vial or every syringe cannot be performed, the sterile filters are checked for their integrity, more precisely for their pore diameter, instead. According to the specifications of the WHO, a pore diameter of maximum 0.2 µm is allowed for sterile filtration [1]; accordingly, filtration with a sterile filter possessing a pore diameter of 0.2 µm or less results in a sterile filtrate.

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Review of the book “Analytische Qualitätskontrolle und pharmazeutische Mikrobiologie” (Analytical Quality Control and Pharmaceutical Microbiology)

Written by Dr. Janet Thode on . Posted in Think out of the box

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).

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Limit tests - (when) do they play a role?

Written by Dr. Janet Thode on . Posted in Method validation

Purity determinations are applied as part of the quality control of pharmaceuticals, their active pharmaceutical ingredients (and, if applicable, their excipients in case they are not yet obtained in compendial quality). This includes quantitative determinations, resulting in a definite statement of the quantity or concentration, as well as qualitative / semi-quantitative determinations with results allowing only conclusions to be drawn as to whether the impurity is present or not or whether it is below a certain limit value. Such determinations are also known as "limit tests". Some people will think back to a laboratory practical training in drug analysis during their studies with more or less enthusiasm when they hear the word "limit test"...

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