Method validation

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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Calculation template for the evaluation of precision during method validations

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

To make work easier, I’d like to continue with our already started template series and today I’d like to post a template that can be used during method validations to evaluate the validation parameter precision (including repeatability, instrumental precision, and two versions for intermediate precision).

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Using the relative response for method validations and routine measurements

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

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.

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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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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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