Method development / validation

BRIEFLY EXPLAINED

Method development

Regardless of whether release testing or stability testing, regardless of whether synthetic or herbal drugs or raw materials have to be analyzed:

Since 1992, we have been developing customized methods for robust, reliable routine operation and have already established methods for testing quality-relevant parameters for more than 400 different active pharmaceutical ingredients.
After the (de novo) development or optimization of a method, we validate it “state-of-the-art” according to the validation plan, in particular according to ICH guidelines.
Of course, customer-specific requirements (SOPs) are also taken into account.
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BRIEFLY EXPLAINED

Method validation

When validating purity, assay and release methods, we define the required scope of validation in close consultation with you. With this specification we check the method specifically for the impact of critical parameters (risk assessment).

If we carry out controlled degradation studies (concerning purity methods), special consideration is given to factors such as light, heat, oxidative, acidic and alkaline stress. Following the risk assessment, we determine the acceptance criteria and record them in the validation plan. Of course, we also carry out validations of established methods according to customer-specific validation plans!

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Validation parameters

Parameter Identity Impurities Content
Quantitative Limit test
Accuracy – x – x
Precision –
Repeatability precision x – x
Comparison precision(1) x – x
Specificity/Selectivity (2) x x x x
Limit of detection “LOD” – 3 x –
Limit of quantification “LOQ” – x – –
Linearity – x – x
Measuring range – x – x

(1) If a laboratory comparison is performed, the reproducibility or “Intermediate Precision” is not applicable.

(2) A lack of specificity can be compensated by a second method

(3) Necessary in certain cases

THE PROCEDURE FOR THE

Validation report

The validation process is completed with the finalization of the validation report.

  • The customer receives this report either in German or English.

  • In the case of more complex projects, our customer first receives a draft of the report, which is then jointly discussed. Upon request, we will also be happy to prepare a corresponding test method.

  • Following their implementation validated methods are verified according to USP<1226>. This ensures that they are used professionally and can be quickly adopted in the routine operation.

  • Successful method development and validation ensures fast and smooth method transfers and thus the fastest possible use of the validated method.

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Do you have an inquiry that you would like to clarify with us?
Then please feel free to call us. For further inquiries you can also contact us by e-mail or use our contact form.

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