Validation of the analytical method is confirmed in the form of examination and formal presentation of the documented evidence confirming that the analytical method is suitable for the intended objective and allows to receive satisfactory results.
The transfer of the analytical method constitutes the process of creating the method in another lab which gives certainty that the analytical method in both laboratories is identical and that it has been transferred in the correct manner.
We also offer the possibility to perform validation of methods prepared by us as well as those submitted by our customers. Validations are performed in accordance with international requirements regarding the validation of analytical methods, including the ICH Q2(R1) guidelines as well as the in internal procedures and / or the procedures of the customer.
The scope of validation is always agreed on in detail with the customer and after validation has been completed, the customer receives a final report.
At the request of the customer we also take care of the transfer of the validated method to another lab.
Our professionals offer help in defining the scope of work connected with the transfer, selection of critical methods and preparation of transfer documentation.
The transfer is carried out in accordance with internal procedures or according to the procedures of the customer.
We also take care of verification (transfer) of the pharmacopoeial methods.