I have a question to those who work in analytical method development and validation in pharma industry. If you want to evaluate a different brand of HPLC instrument during validation (eg. the method is developed in Agilent but you also want to evaluate Waters), which tests do you run within the validation? Do you consider it under intermediate precision or is it just the robustness test on a different brand of HPLC? And do you know if there are any indications regarding the issue in any of the guidelines?
Many thanks,
Nur
If it is a compendia method you need only system robustness, but if it is a new developed method you need to do partial validation. See ICHQ2 guideline, USP general chapter and ” Practical HPLC method development, 2nd edition by Lloyd R. Snyder.
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Thanks
You run everything, as two different brands of HPLC systems will have different hardware and probably CDS software too (pumps, detectors, flow cells, samplers, tubing, parameters, software ...). Only the column and mobile phase would be the same.
If it is a compendia method you need only system robustness, but if it is a new developed method you need to do partial validation. See ICHQ2 guideline, USP general chapter and ” Practical HPLC method development, 2nd edition by Lloyd R. Snyder.
In my opinion everything depend on what you need. First of all, your analytical instruments should be equivalent and you prove it by qualification of analytical instruments which include a several tests (precision, accuracy, carryover, linearity etc). I mean that precision of your chromatograph systems are the same lower than 1 %.
In my opinion, the aim of validation is to prove that method is acceptable to inner application. Of course it is necessary always to take into account all uncertainty sourse as possible, esspesial unstandartized, which you cannot predict. Different type of instruments, analytics etc could be those sourses and in this case it is necessary to check it how different analytics or instruments could reproduce the method, I guess it is important when we have the gradient. In this case we need to evaluate the robust of method, however, trough evaluating of validation characteristics (precision, accuracy etc.)
From the other side, your all instrument should be equivalent as I wrote and meet the requirements of qualification, for example, precision should be lower than 1 %. However, in this case 1st system could have precision 0.9% and 2nd - 0.1 %. If you would like to evaluate total unsertainty of method you should design experiment in such manner that method faces all possible sourse of uncertainty. In this case it is imporant to evaluate precision of methods.
Always we need to remember and use the 2nd princeple of ICH Q9: "The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk". Therefore often analytics try to combine the tests into the group and check them together to safe the time and efforts.
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