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Template for linearity calculations of method validations

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

During method validations in pharmaceutical QC laboratories or commissioned contract laboratories, different validation parameters have to be checked. For quantitative impurity determinations and assays, such as content determinations of the active pharmaceutical ingredient or potency tests, studies of the linearity are required according to the method validation guideline ICH Q2(R1).

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Review of the book “Die Pharmaindustrie” (the pharmaceutical industry)

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

Since I was once more browsing for new books at Amazon, I was delighted (and shocked) to see that the next edition of the book "Die Pharmaindustrie" by Dagmar Fischer and Jörg Breitenbach (currently: 4th edition from 2013, published by Springer-Verlag Berlin Heidelberg, ISBN: 978-3-8274-2923-0) * will soon be published in October.

Delighted, because I am generally very enthusiastic about this book and shocked, because this means I should quickly write a review of the 4th edition to describe my impressions. I have to admit, this book has been with me a little longer and I've always read individual chapters (and commented for myself) from time to time, but not devoured the entire book in one go. Now is absolutely the time to take stock ;-)

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Intermediate precision

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

When evaluating quantitative analytical quality control methods regarding their fitness for purpose during method validation, the validation parameter “intermediate precision” must also be considered. The term “intermediate precision” might also appear under the following names:

  • within-laboratory reproducibility or intralaboratory reproducibility
  • within-lab(oratory) / within-device precision
  • inter-assay precision / between-run precision
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Template method validation plan all tests

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

Templates make life easier. This is true in every field of life. Since this blog is about topics in pharmaceutical laboratories, especially method validation, method verification and method transfer, we have started to provide templates for the validation of analytical methods according to ICH Q2(R1) considering their method type (identification method, impurity test or assay).

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