I have fully validated an analytical method in HPLC and now following the purchase of a new instrument (same brand new model) I will have to do the partial validation. Unfortunately, EMA does not say which parameters to evaluate and what to do by specifying.
Could it be enough to inject QCs and make precision and accuracy?
- Fabiola Carrara wrote: "a new instrument (same brand new model)" ;
*This needs to be addressed first.
Has the "new" HPLC instrument passed a formal Installation Qualification (IQ) and Operation Qualification (OQ) yet? Brand being the same does not mean much. The two instrument models and configurations are likely to be different, so full Verifications are needed first.
Next, if you want to run a method on the new system, you may need full method validation for THAT instrument (same as if transferring the method to a different system, depends on what differences are noted). If it is configured differently, plumbed differently, set-up differently or has different modules, it is different and changes to the method may need to be made. Have the HPLC system and specific method used passed System Suitability? More info is needed. Is there someone at your location who can help you?
Hi,
"In situations where minor changes are made to an analytical method that has already been validated, a full validation may not be necessary, depending on the nature of the applied changes. Changes for which a partial validation may be needed include transfer of the bioanalytical method to another laboratory, change in equipment, calibration concentration range, limited sample volume, another matrix or species, change in anticoagulant, sample processing procedure, storage conditions etc. All modifications should be reported and the scope of revalidation or partial validation justified. Partial validation can range from as little as the determination of the within-run precision and accuracy, to an almost full validation."
"If the calibration curve range is changed, the bioanalytical method should be revalidated (partial validation) to verify the response function and to ensure accuracy and precision."
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf
"The degree of revalidation required depends on the nature of the changes."
https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf
Hope it helps,
Best regards
Tomasz
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