Bioequivalence and Bioavailability Forum

Dear esreddy,
If you are moving the whole Bioanalytical facility (equipments too) then after installation you will have to calibrate the machines and confirm if it meets the vendor's specifications (for e.g. for LC-MS/MS we inject PPG and check whether we meet the acceptance criteria).

Then, please refer the 'Guidance for Industry, Bioanalytical Method Validation--B'. 'Partial Validation- first point i.e. Bioanalytical method transfers between laboratories or analysts'.

You can analyze a single Precision and Accuracy batch. And it will be the amendment to 'Method Validation Protocol and Report' (an addendum for 'Ruggedness'). And if it's good I think there shouldn't be any problem regulatory point of view.

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Edit: Full quote removed. Please see this post - and that one also! Since nobody is willing to read, writing obviously is a hard business too. Slowly I'm getting fed up. [Jaime]