A wide variety of analysis methods are used in the pharmaceutical quality control laboratory. In addition to methods to proof the identity of the active pharmaceutical ingredient and qualitative tests, quantitative determinations are also included. A (calibration) standard of different concentrations is run in parallel within each analysis and the intensity of the measurement signal (detector response) is then plotted against the concentration.
If you are just approaching the topic of method validation, you may be faced with the question which analytical methods are actually affected by method validation.
To answer this question, we have to clarify which methods are used when and for what purpose.
And once again a technical book accompanied me on vacation and aided in avoiding my gray matter to rust completely ;-)
I’d like to use this blog article to describe my impressions of the book “Drug Development and Market Authorization” by Niels Eckstein (2nd edition from 2018, published by Deutscher Apotheker Verlag Stuttgart, ISBN: 978-3-7692-6992-5).
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).
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 ;-)
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
Just like my last book review, I’d like to take a humorous excursion into the world of microbes once more.
This time, I’d like to briefly describe my impressions of the book “The other end of the microscope” by Elmer W. Koneman (2003, Spektrum Akademischer Verlag GmbH Heidelberg Berlin, ISBN: 3-8274-1459-8 *).
What has changed at the Loesungsfabrik due to the current COVID-19 pandemic?
Nothing ... as far as ... nothing at all.
Well, not totally, but almost.